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SAS Institute: SMB Study - Small Banks Lead in AI - But Scale Lags
CARY, North Carolina, Sept. 26 (TNSrpt) -- SAS Institute, a business analytics software and services provider, issued the following news release:
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SMB study: Small banks lead in AI - but scale lags
AI use hits 64% in IT, but infrastructure and governance constrain broader deployment; new tool helps institutions see where they stand
Cary, NC (Sep 25, 2026)
As AI use proliferates in the SMB sector, small banks, credit unions and lenders have put banking on the AI leaderboard - ahead of similarly sized firms in insurance, government, health care and life sciences - according to a recent ... Show Full Article CARY, North Carolina, Sept. 26 (TNSrpt) -- SAS Institute, a business analytics software and services provider, issued the following news release: * * * SMB study: Small banks lead in AI - but scale lags AI use hits 64% in IT, but infrastructure and governance constrain broader deployment; new tool helps institutions see where they stand Cary, NC (Sep 25, 2026) As AI use proliferates in the SMB sector, small banks, credit unions and lenders have put banking on the AI leaderboard - ahead of similarly sized firms in insurance, government, health care and life sciences - according to a recentAI readiness study by SAS, with research and analysis by IDC. Even so, the findings suggest institution-wide AI remains elusive.
The study, AI for SMBs: Closing the Readiness Reality Gap, is based on a survey of 1,600 small and midsized business (SMB) leaders across 28 countries in five global regions. SMBs were defined as organizations with 100 to 999 employees in the U.S. and 100 to 499 employees in other markets.
Among five SMB industries examined, financial institutions show the strongest strategic alignment, most established governance practices and greatest integration of AI into day-to-day operations. Yet the study's banking AI readiness findings/* also expose significant growing pains:
- AI use is concentrated in IT. Nearly two-thirds (64%) of small financial institutions use AI in IT. That's compared with 47% in finance and risk, 44% in marketing, 42% in customer service and 39% in product development.
- Infrastructure is often a bottleneck. About 2 in 5 respondents (39%) say their infrastructure is not ready, or is too costly, for broader AI deployment.
- Governance concerns loom large. Security, privacy and compliance concerns are the top barrier to scaling AI, cited by 40% of small financial institutions.
- Fragmentation creates another drag. One-third (33%) cite the lack of a unified data, analytics and AI platform among their AI challenges.
The findings arrive as SAS heads to Sibos, Sept. 28 - Oct. 1 in Miami, where its experts will lead discussions on AI readiness, trust, agentic AI, payments and financial crime. Attendees can connect with SAS at Booth I073 throughout the conference.
"For smaller financial institutions, scaling AI does not mean recreating the technology architecture of a global bank," said Chris Marshall, Vice President of Financial Services at IDC. "The smarter path is to focus internal resources where they create the most value and lean on technology and implementation partners to extend what the institution can accomplish on its own. The right ecosystem and the right collaborators can turn integration complexity into a manageable, even accelerated, path forward."
Where small-bank AI goes next
Banking respondents' top-cited near-term AI priorities show greater focus on practical capabilities than novelty:
- Automating and streamlining core business processes (30%).
- Reducing costs through efficiency and automation (30%).
- Improving data quality and integration (28%).
- Increasing product and service innovation (26%).
Banking also leads the SMB industries studied in moving beyond isolated AI pilots. The most advanced institutions aren't just adding more use cases but strengthening the foundations beneath.
"AI pilots often become islands of innovation," said Alex Kwiatkowski, Director of Global Financial Services at SAS. "One team builds a high-impact fraud use case. Another launches a sharper risk model. A third automates a process. Each initiative delivers tangible benefits, but they don't add up to an AI strategy.
"Real transformation requires organizations to bridge those islands - connecting siloed functions and decisioning capabilities through shared data, governance and infrastructure - so AI travels farther and faster across the organization."
AI's bigger payoff lies beyond IT, where it currently dominates. Expanding adoption across finance and risk, and into more customer-focused areas like marketing, customer service and product development, can compound isolated gains into more consequential, institution-wide returns - strengthening fraud and risk management, customer experience, product innovation and more.
On Oct. 16, SAS will host a webinar to further explore these issues. AI Readiness vs. Reality: Moving Beyond the Hype in Banking and Insurance will focus on practical, responsible strategies for turning AI ambition into business impact.
How AI-ready is your institution?
Small and midsized banks and credit unions can benchmark their own AI maturity with SAS' AI Readiness Calculator. The 11-question assessment, based on the SAS and IDC AI Readiness Index, evaluates organizations across planning, building, enabling and executing.
Each participant receives a personalized report highlighting strengths, readiness gaps and recommended next steps based on the institution's maturity stage, priorities and industry.
For more on applying AI across risk, fraud and customer experience, explore SAS' AI in Banking resources.
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*/ Source: IDC Resource Map Document, sponsored by SAS, SMB AI Readiness, Doc. #EUR154930226 [May 2026].
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About SAS
SAS is a global leader in data and AI, helping organizations make confident decisions with AI they can trust. For decades, SAS has set the standard for delivering software that drives meaningful impact, incorporating deep industry expertise, transparency and governance. SAS gives you THE POWER TO KNOW(R).
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REPORT: https://www.sas.com/content/dam/sasdam/documents/20260302/ai-for-smbs-closing-the-readiness-reality-gap-full-report.pdf
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Original text here: https://www.sas.com/en_us/news/press-releases/2026/september/idc-smb-study-banking.html
[Category: BizComputer Technology]
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SMB study: Small banks lead in AI - but scale lags
AI use hits 64% in IT, but infrastructure and governance constrain broader deployment; new tool helps institutions see where they stand
Cary, NC (Sep 25, 2026)
As AI use proliferates in the SMB sector, small banks, credit unions and lenders have put banking on the AI leaderboard - ahead of similarly sized firms in insurance, government, health care and life sciences - according to a recent ... Show Full Article CARY, North Carolina, Sept. 26 (TNSrpt) -- SAS Institute, a business analytics software and services provider, issued the following news release: * * * SMB study: Small banks lead in AI - but scale lags AI use hits 64% in IT, but infrastructure and governance constrain broader deployment; new tool helps institutions see where they stand Cary, NC (Sep 25, 2026) As AI use proliferates in the SMB sector, small banks, credit unions and lenders have put banking on the AI leaderboard - ahead of similarly sized firms in insurance, government, health care and life sciences - according to a recentAI readiness study by SAS, with research and analysis by IDC. Even so, the findings suggest institution-wide AI remains elusive.
The study, AI for SMBs: Closing the Readiness Reality Gap, is based on a survey of 1,600 small and midsized business (SMB) leaders across 28 countries in five global regions. SMBs were defined as organizations with 100 to 999 employees in the U.S. and 100 to 499 employees in other markets.
Among five SMB industries examined, financial institutions show the strongest strategic alignment, most established governance practices and greatest integration of AI into day-to-day operations. Yet the study's banking AI readiness findings/* also expose significant growing pains:
- AI use is concentrated in IT. Nearly two-thirds (64%) of small financial institutions use AI in IT. That's compared with 47% in finance and risk, 44% in marketing, 42% in customer service and 39% in product development.
- Infrastructure is often a bottleneck. About 2 in 5 respondents (39%) say their infrastructure is not ready, or is too costly, for broader AI deployment.
- Governance concerns loom large. Security, privacy and compliance concerns are the top barrier to scaling AI, cited by 40% of small financial institutions.
- Fragmentation creates another drag. One-third (33%) cite the lack of a unified data, analytics and AI platform among their AI challenges.
The findings arrive as SAS heads to Sibos, Sept. 28 - Oct. 1 in Miami, where its experts will lead discussions on AI readiness, trust, agentic AI, payments and financial crime. Attendees can connect with SAS at Booth I073 throughout the conference.
"For smaller financial institutions, scaling AI does not mean recreating the technology architecture of a global bank," said Chris Marshall, Vice President of Financial Services at IDC. "The smarter path is to focus internal resources where they create the most value and lean on technology and implementation partners to extend what the institution can accomplish on its own. The right ecosystem and the right collaborators can turn integration complexity into a manageable, even accelerated, path forward."
Where small-bank AI goes next
Banking respondents' top-cited near-term AI priorities show greater focus on practical capabilities than novelty:
- Automating and streamlining core business processes (30%).
- Reducing costs through efficiency and automation (30%).
- Improving data quality and integration (28%).
- Increasing product and service innovation (26%).
Banking also leads the SMB industries studied in moving beyond isolated AI pilots. The most advanced institutions aren't just adding more use cases but strengthening the foundations beneath.
"AI pilots often become islands of innovation," said Alex Kwiatkowski, Director of Global Financial Services at SAS. "One team builds a high-impact fraud use case. Another launches a sharper risk model. A third automates a process. Each initiative delivers tangible benefits, but they don't add up to an AI strategy.
"Real transformation requires organizations to bridge those islands - connecting siloed functions and decisioning capabilities through shared data, governance and infrastructure - so AI travels farther and faster across the organization."
AI's bigger payoff lies beyond IT, where it currently dominates. Expanding adoption across finance and risk, and into more customer-focused areas like marketing, customer service and product development, can compound isolated gains into more consequential, institution-wide returns - strengthening fraud and risk management, customer experience, product innovation and more.
On Oct. 16, SAS will host a webinar to further explore these issues. AI Readiness vs. Reality: Moving Beyond the Hype in Banking and Insurance will focus on practical, responsible strategies for turning AI ambition into business impact.
How AI-ready is your institution?
Small and midsized banks and credit unions can benchmark their own AI maturity with SAS' AI Readiness Calculator. The 11-question assessment, based on the SAS and IDC AI Readiness Index, evaluates organizations across planning, building, enabling and executing.
Each participant receives a personalized report highlighting strengths, readiness gaps and recommended next steps based on the institution's maturity stage, priorities and industry.
For more on applying AI across risk, fraud and customer experience, explore SAS' AI in Banking resources.
* * *
*/ Source: IDC Resource Map Document, sponsored by SAS, SMB AI Readiness, Doc. #EUR154930226 [May 2026].
* * *
About SAS
SAS is a global leader in data and AI, helping organizations make confident decisions with AI they can trust. For decades, SAS has set the standard for delivering software that drives meaningful impact, incorporating deep industry expertise, transparency and governance. SAS gives you THE POWER TO KNOW(R).
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REPORT: https://www.sas.com/content/dam/sasdam/documents/20260302/ai-for-smbs-closing-the-readiness-reality-gap-full-report.pdf
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Original text here: https://www.sas.com/en_us/news/press-releases/2026/september/idc-smb-study-banking.html
[Category: BizComputer Technology]
Morgan Lewis Advises Biolevate on Its Series A Funding Round
PHILADELPHIA, Pennsylvania, Sept. 26 -- Morgan Lewis, a law firm, issued the following news release:
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Morgan Lewis Advises Biolevate on its Series A Funding Round
PARIS, September 25, 2026: Morgan Lewis advised Biolevate, a French AI company dedicated to life sciences, in connection with its Euros30 million (approximately $34.1 million) Series A funding round. The round was co-led by RAISE France, the investment vehicle of entrepreneur Aymar Henin, and Orange Ventures, with participation from the MSD Global Health Innovation Fund, Station F, and existing investor EQT Ventures.
This round ... Show Full Article PHILADELPHIA, Pennsylvania, Sept. 26 -- Morgan Lewis, a law firm, issued the following news release: * * * Morgan Lewis Advises Biolevate on its Series A Funding Round PARIS, September 25, 2026: Morgan Lewis advised Biolevate, a French AI company dedicated to life sciences, in connection with its Euros30 million (approximately $34.1 million) Series A funding round. The round was co-led by RAISE France, the investment vehicle of entrepreneur Aymar Henin, and Orange Ventures, with participation from the MSD Global Health Innovation Fund, Station F, and existing investor EQT Ventures. This roundfollows the company's Euros6 million (approximately $6.8 million) seed round in November 2024, which was led by EQT Ventures.
Founded in Paris by a team of former Dataiku engineers and AI researchers, Biolevate develops an agentic AI platform spanning the full life sciences value chain, including research, clinical trials, health technology assessments, regulatory dossiers, and drug discovery and development.
The new funding will enable Biolevate to strengthen its product capabilities and accelerate its international expansion, including the opening of a Boston office.
The Morgan Lewis team advising Biolevate included partner Sebastien Pontillo, associate Thomas Maincent, and jurist Carole Ruggiu on the corporate aspects, and partner Mathilde Carle on IP matters.
For more information, read Biolevate's announcement (https://www.biolevate.com/news/series-a-2026).
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URL: Biolevate
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Original text here: https://www.morganlewis.com/news/2026/09/morgan-lewis-advises-biolevate-on-its-series-a-funding-round
[Category: BizLaw/Legal]
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Morgan Lewis Advises Biolevate on its Series A Funding Round
PARIS, September 25, 2026: Morgan Lewis advised Biolevate, a French AI company dedicated to life sciences, in connection with its Euros30 million (approximately $34.1 million) Series A funding round. The round was co-led by RAISE France, the investment vehicle of entrepreneur Aymar Henin, and Orange Ventures, with participation from the MSD Global Health Innovation Fund, Station F, and existing investor EQT Ventures.
This round ... Show Full Article PHILADELPHIA, Pennsylvania, Sept. 26 -- Morgan Lewis, a law firm, issued the following news release: * * * Morgan Lewis Advises Biolevate on its Series A Funding Round PARIS, September 25, 2026: Morgan Lewis advised Biolevate, a French AI company dedicated to life sciences, in connection with its Euros30 million (approximately $34.1 million) Series A funding round. The round was co-led by RAISE France, the investment vehicle of entrepreneur Aymar Henin, and Orange Ventures, with participation from the MSD Global Health Innovation Fund, Station F, and existing investor EQT Ventures. This roundfollows the company's Euros6 million (approximately $6.8 million) seed round in November 2024, which was led by EQT Ventures.
Founded in Paris by a team of former Dataiku engineers and AI researchers, Biolevate develops an agentic AI platform spanning the full life sciences value chain, including research, clinical trials, health technology assessments, regulatory dossiers, and drug discovery and development.
The new funding will enable Biolevate to strengthen its product capabilities and accelerate its international expansion, including the opening of a Boston office.
The Morgan Lewis team advising Biolevate included partner Sebastien Pontillo, associate Thomas Maincent, and jurist Carole Ruggiu on the corporate aspects, and partner Mathilde Carle on IP matters.
For more information, read Biolevate's announcement (https://www.biolevate.com/news/series-a-2026).
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URL: Biolevate
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Original text here: https://www.morganlewis.com/news/2026/09/morgan-lewis-advises-biolevate-on-its-series-a-funding-round
[Category: BizLaw/Legal]
Marcus & Millichap Arranges Sale of 92-Room Fairfield Inn & Suites in Goshen, Indiana
ENCINO, California, Sept. 26 -- Marcus and Millichap issued the following news release:
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Marcus & Millichap Arranges Sale of 92-Room Fairfield Inn & Suites in Goshen, Indiana
GOSHEN, Ind., Sept. 25, 2026 - Marcus & Millichap (NYSE: MMI), a leading commercial real estate brokerage firm specializing in investment sales, financing, research and advisory services, announced today the sale of a 92-room Fairfield Inn & Suites in Goshen, Indiana.
"We're pleased to have completed this transaction for both the buyer and seller," said Michael Klar, investment specialist with Marcus & Millichap. ... Show Full Article ENCINO, California, Sept. 26 -- Marcus and Millichap issued the following news release: * * * Marcus & Millichap Arranges Sale of 92-Room Fairfield Inn & Suites in Goshen, Indiana GOSHEN, Ind., Sept. 25, 2026 - Marcus & Millichap (NYSE: MMI), a leading commercial real estate brokerage firm specializing in investment sales, financing, research and advisory services, announced today the sale of a 92-room Fairfield Inn & Suites in Goshen, Indiana. "We're pleased to have completed this transaction for both the buyer and seller," said Michael Klar, investment specialist with Marcus & Millichap."From the initial stages through closing, both parties worked collaboratively and remained committed to the sale, helping maintain momentum throughout the process."
Klar and Ebrahim Valliani from the firm's Chicago Oak Brook office, represented both the buyer and seller in the transaction, in association with Julia Evinger, Marcus & Millichap's Indiana broker of record. The transaction received additional support from Allan Miller and Chris Gomes of the Miller-Gomes Hotel Team.
"Investment activity in Indiana's hospitality sector continues to be active, particularly for newer hotel assets in strong regional markets," said Valliani. "Our team was able to work closely with both sides to keep the transaction moving forward, and we congratulate both the buyer and seller on a successful closing."
Fairfield Inn & Suites Goshen is located at 2110 Keystone Drive. The four-story hotel was built in 2019 and features an indoor swimming pool, fitness center, business center, meeting space and guest laundry facilities.
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About Marcus & Millichap, Inc. (NYSE: MMI)
Marcus & Millichap, Inc. is a leading brokerage firm specializing in commercial real estate investment sales, financing, research and advisory services with offices throughout the United States and Canada. As of December 31, 2025, the company had 1,808 investment sales and financing professionals in over 80 offices who provide investment brokerage and financing services to sellers and buyers of commercial real estate. The company also offers market research, consulting and advisory services to clients. Marcus & Millichap closed 8,818 transactions in 2025, with a sales volume of approximately $50.9 billion. For additional information, please visit www.MarcusMillichap.com.
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Original text here: https://www.marcusmillichap.com/news-events/press/2026/09/09-25-fairfieldinngoshen
[Category: BizRealEstate]
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Marcus & Millichap Arranges Sale of 92-Room Fairfield Inn & Suites in Goshen, Indiana
GOSHEN, Ind., Sept. 25, 2026 - Marcus & Millichap (NYSE: MMI), a leading commercial real estate brokerage firm specializing in investment sales, financing, research and advisory services, announced today the sale of a 92-room Fairfield Inn & Suites in Goshen, Indiana.
"We're pleased to have completed this transaction for both the buyer and seller," said Michael Klar, investment specialist with Marcus & Millichap. ... Show Full Article ENCINO, California, Sept. 26 -- Marcus and Millichap issued the following news release: * * * Marcus & Millichap Arranges Sale of 92-Room Fairfield Inn & Suites in Goshen, Indiana GOSHEN, Ind., Sept. 25, 2026 - Marcus & Millichap (NYSE: MMI), a leading commercial real estate brokerage firm specializing in investment sales, financing, research and advisory services, announced today the sale of a 92-room Fairfield Inn & Suites in Goshen, Indiana. "We're pleased to have completed this transaction for both the buyer and seller," said Michael Klar, investment specialist with Marcus & Millichap."From the initial stages through closing, both parties worked collaboratively and remained committed to the sale, helping maintain momentum throughout the process."
Klar and Ebrahim Valliani from the firm's Chicago Oak Brook office, represented both the buyer and seller in the transaction, in association with Julia Evinger, Marcus & Millichap's Indiana broker of record. The transaction received additional support from Allan Miller and Chris Gomes of the Miller-Gomes Hotel Team.
"Investment activity in Indiana's hospitality sector continues to be active, particularly for newer hotel assets in strong regional markets," said Valliani. "Our team was able to work closely with both sides to keep the transaction moving forward, and we congratulate both the buyer and seller on a successful closing."
Fairfield Inn & Suites Goshen is located at 2110 Keystone Drive. The four-story hotel was built in 2019 and features an indoor swimming pool, fitness center, business center, meeting space and guest laundry facilities.
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About Marcus & Millichap, Inc. (NYSE: MMI)
Marcus & Millichap, Inc. is a leading brokerage firm specializing in commercial real estate investment sales, financing, research and advisory services with offices throughout the United States and Canada. As of December 31, 2025, the company had 1,808 investment sales and financing professionals in over 80 offices who provide investment brokerage and financing services to sellers and buyers of commercial real estate. The company also offers market research, consulting and advisory services to clients. Marcus & Millichap closed 8,818 transactions in 2025, with a sales volume of approximately $50.9 billion. For additional information, please visit www.MarcusMillichap.com.
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Original text here: https://www.marcusmillichap.com/news-events/press/2026/09/09-25-fairfieldinngoshen
[Category: BizRealEstate]
Maj Invest Selects Bloomberg's BQuant Enterprise to Power Firm-Wide Research Innovation
NEW YORK, Sept. 26 -- Bloomberg issued the following news:
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Maj Invest Selects Bloomberg's BQuant Enterprise to Power Firm-Wide Research Innovation
September 25, 2026
Maj Invest, one of Denmark's largest independent investment houses, has selected Bloomberg's public cloud-based analytics platform, BQuant Enterprise, to accelerate and deepen the firm's investment research process, improve productivity, and generate insights that support Maj Invest in continuing to serve clients to the highest standard.
The deployment marks a significant modernisation in how Maj Invest develops and scales ... Show Full Article NEW YORK, Sept. 26 -- Bloomberg issued the following news: * * * Maj Invest Selects Bloomberg's BQuant Enterprise to Power Firm-Wide Research Innovation September 25, 2026 Maj Invest, one of Denmark's largest independent investment houses, has selected Bloomberg's public cloud-based analytics platform, BQuant Enterprise, to accelerate and deepen the firm's investment research process, improve productivity, and generate insights that support Maj Invest in continuing to serve clients to the highest standard. The deployment marks a significant modernisation in how Maj Invest develops and scalesits analytical capabilities; moving from individual tools to a shared analytics platform in which any team can build, test and deploy models or internal solutions that address their specific investment and operational challenges.
BQuant Enterprise's flexible Python environment gives analysts and researchers broad programmatic access to Bloomberg's comprehensive range of high quality financial and alternative datasets, combined with advanced compute capabilities and open source data science libraries in its secure, Bloomberg-managed sandbox environment. This enables the firm to rapidly build, test and refine investment models, and to share outputs with permissioned colleagues across the firm as interactive BQuant Published Applications. This reduces the time and technical overhead typically required to bring new analytical capabilities to market within an investment firm.
Because investment strategies are built and tested in a secure sandbox environment with access to consistent, high-quality data, the firm can iterate quickly, share BQuant Published Apps across teams via Bloomberg Launchpad, and preserve version control and governance without creating fragmented or siloed infrastructure.
Since deploying BQuant Enterprise, Maj Invest's teams have built a range of solutions across its investment process, from screening and scoring models to research dashboards, including a proprietary model that treats financial ratios as tokens within a purely financial context in order to forecast the most likely stock outcomes.
"Bloomberg's BQuant Enterprise has become the tool for how we build and scale analytical capabilities across the whole firm," said Kurt Kara, Head of Equities at Maj Invest. "Analysts and research teams no longer need to rely on static models or fragmented systems. Instead, they benefit from building and testing models and related solutions within one analytics platform and can rapidly deploy these solutions across the team. The quality of service from Bloomberg has also been a key part of this success, with responsive, knowledgeable support helping our teams get the most out of BQuant Enterprise."
"Investment firms increasingly need to turn high-quality data into differentiated insights and workflows at speed," said Javier Mitra Valdes, Head of Product for the BQuant Platform at Bloomberg. "With BQuant Enterprise, Maj Invest can bring Bloomberg's data, analytics and quantitative capabilities together in one secure environment, giving its teams the flexibility to experiment, build and scale proprietary models and related solutions across its investment process. This supports Maj Invest as it continues to strengthen its research capabilities and drive innovation across their firm."
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About BQuant Enterprise
BQuant Enterprise is a cloud-based analytics platform specifically designed for quantitative analysts and data scientists in the financial markets. BQuant Enterprise provides broad programmatic access to Bloomberg's comprehensive range of high-quality market-leading financial datasets and services via powerful APIs, along with quant tools. This solution significantly reduces time to market and infrastructure costs for developing new investment strategies across asset classes. BQuant Enterprise provides a flexible Python environment to build, test, and take sophisticated quant models to market. Learn more about BQuant Enterprise.
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About Bloomberg
Bloomberg is a global leader in business and financial information, delivering trusted data, news, and insights that bring transparency, efficiency, and fairness to markets. The company helps connect influential communities across the global financial ecosystem via reliable technology solutions that enable our customers to make more informed decisions and foster better collaboration.
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About Maj Invest
Maj Invest is one of Denmark's largest independent investment firms. We provide investment management and advisory services to institutional, professional and private clients in Denmark and internationally.
Our approach is rooted in independent analysis, deep market knowledge and a long-term perspective. Maj Invest's employees are co-owners of the firm, aligning our interests with those of our clients.
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URL: BQuant Enterprise
URL: Maj Invest
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Original text here: https://www.bloomberg.com/company/press/maj-invest-selects-bloombergs-bquant-enterprise-to-power-firm-wide-research-innovation/
[Category: BizMedia]
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Maj Invest Selects Bloomberg's BQuant Enterprise to Power Firm-Wide Research Innovation
September 25, 2026
Maj Invest, one of Denmark's largest independent investment houses, has selected Bloomberg's public cloud-based analytics platform, BQuant Enterprise, to accelerate and deepen the firm's investment research process, improve productivity, and generate insights that support Maj Invest in continuing to serve clients to the highest standard.
The deployment marks a significant modernisation in how Maj Invest develops and scales ... Show Full Article NEW YORK, Sept. 26 -- Bloomberg issued the following news: * * * Maj Invest Selects Bloomberg's BQuant Enterprise to Power Firm-Wide Research Innovation September 25, 2026 Maj Invest, one of Denmark's largest independent investment houses, has selected Bloomberg's public cloud-based analytics platform, BQuant Enterprise, to accelerate and deepen the firm's investment research process, improve productivity, and generate insights that support Maj Invest in continuing to serve clients to the highest standard. The deployment marks a significant modernisation in how Maj Invest develops and scalesits analytical capabilities; moving from individual tools to a shared analytics platform in which any team can build, test and deploy models or internal solutions that address their specific investment and operational challenges.
BQuant Enterprise's flexible Python environment gives analysts and researchers broad programmatic access to Bloomberg's comprehensive range of high quality financial and alternative datasets, combined with advanced compute capabilities and open source data science libraries in its secure, Bloomberg-managed sandbox environment. This enables the firm to rapidly build, test and refine investment models, and to share outputs with permissioned colleagues across the firm as interactive BQuant Published Applications. This reduces the time and technical overhead typically required to bring new analytical capabilities to market within an investment firm.
Because investment strategies are built and tested in a secure sandbox environment with access to consistent, high-quality data, the firm can iterate quickly, share BQuant Published Apps across teams via Bloomberg Launchpad, and preserve version control and governance without creating fragmented or siloed infrastructure.
Since deploying BQuant Enterprise, Maj Invest's teams have built a range of solutions across its investment process, from screening and scoring models to research dashboards, including a proprietary model that treats financial ratios as tokens within a purely financial context in order to forecast the most likely stock outcomes.
"Bloomberg's BQuant Enterprise has become the tool for how we build and scale analytical capabilities across the whole firm," said Kurt Kara, Head of Equities at Maj Invest. "Analysts and research teams no longer need to rely on static models or fragmented systems. Instead, they benefit from building and testing models and related solutions within one analytics platform and can rapidly deploy these solutions across the team. The quality of service from Bloomberg has also been a key part of this success, with responsive, knowledgeable support helping our teams get the most out of BQuant Enterprise."
"Investment firms increasingly need to turn high-quality data into differentiated insights and workflows at speed," said Javier Mitra Valdes, Head of Product for the BQuant Platform at Bloomberg. "With BQuant Enterprise, Maj Invest can bring Bloomberg's data, analytics and quantitative capabilities together in one secure environment, giving its teams the flexibility to experiment, build and scale proprietary models and related solutions across its investment process. This supports Maj Invest as it continues to strengthen its research capabilities and drive innovation across their firm."
* * *
About BQuant Enterprise
BQuant Enterprise is a cloud-based analytics platform specifically designed for quantitative analysts and data scientists in the financial markets. BQuant Enterprise provides broad programmatic access to Bloomberg's comprehensive range of high-quality market-leading financial datasets and services via powerful APIs, along with quant tools. This solution significantly reduces time to market and infrastructure costs for developing new investment strategies across asset classes. BQuant Enterprise provides a flexible Python environment to build, test, and take sophisticated quant models to market. Learn more about BQuant Enterprise.
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About Bloomberg
Bloomberg is a global leader in business and financial information, delivering trusted data, news, and insights that bring transparency, efficiency, and fairness to markets. The company helps connect influential communities across the global financial ecosystem via reliable technology solutions that enable our customers to make more informed decisions and foster better collaboration.
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About Maj Invest
Maj Invest is one of Denmark's largest independent investment firms. We provide investment management and advisory services to institutional, professional and private clients in Denmark and internationally.
Our approach is rooted in independent analysis, deep market knowledge and a long-term perspective. Maj Invest's employees are co-owners of the firm, aligning our interests with those of our clients.
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URL: BQuant Enterprise
URL: Maj Invest
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Original text here: https://www.bloomberg.com/company/press/maj-invest-selects-bloombergs-bquant-enterprise-to-power-firm-wide-research-innovation/
[Category: BizMedia]
Johnson & Johnson: Single Infusion of Carvykti Delivered Five-year Treatment-free Remissions in 50% of Patients in Early Line Relapsed/refractory Multiple Myeloma
RARITAN, New Jersey, Sept. 26 -- Johnson and Johnson Innovative Medicine issued the following news release:
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Single infusion of CARVYKTI(R) (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma
* New results suggest earlier treatment may increase the likelihood of long-term remission
* Study adds to Johnson & Johnson's overwhelming body of evidence supporting its innovative multiple myeloma therapies in second line, where earlier intervention may increase long-term remission and disease control
-
RARITAN, ... Show Full Article RARITAN, New Jersey, Sept. 26 -- Johnson and Johnson Innovative Medicine issued the following news release: * * * Single infusion of CARVYKTI(R) (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma * New results suggest earlier treatment may increase the likelihood of long-term remission * Study adds to Johnson & Johnson's overwhelming body of evidence supporting its innovative multiple myeloma therapies in second line, where earlier intervention may increase long-term remission and disease control - RARITAN,N.J., September 25, 2026 - Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced today new long-term follow-up data from the initial subgroup of cohort A in the Phase 2 CARTITUDE-2 study (N=20) showing that 50% of patients (10/20) in early line relapsed or refractory multiple myeloma (RRMM) who were treated with a single infusion of CARVYKTI(R) (ciltacabtagene autoleucel; cilta-cel) remained alive and progression-free for at least five years without maintenance therapy./1 These results build on the durable, treatment-free remissions observed in the CARTITUDE-1 study, which evaluated patients in later lines of therapy, and reinforce that earlier treatment with CARVYKTI(R) may increase long-term remission and disease control. Together, these findings add to the emerging evidence suggesting that CARVYKTI(R) may have curative potential in some patients.
Findings were presented at the International Myeloma Society (IMS) Annual Meeting (Abstract #PA-288).
Expert and company perspectives on earlier treatment-free remissions with CARVYKTI(R)
"Five years ago, treatment-free remissions of this duration were difficult to imagine for many patients with relapsed or refractory multiple myeloma," said Niels van de Donk, M.D., Ph.D., Professor of Hematology, University Medical Center, Amsterdam, the Netherlands.* "These new CARVYKTI findings provide additional evidence that when highly effective, established therapies are used earlier in the disease course, more patients may have the opportunity to achieve deep, durable remissions and long-term disease control without maintenance."
"These results add to the growing body of evidence suggesting that CARVYKTI may have curative potential for some patients, and reinforce the value of bringing highly effective therapies to patients earlier in their treatment journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "As we continue to advance a portfolio of complementary and combinable therapies, these findings reinforce our commitment to pursuing curative approaches and redefining what patients can expect from multiple myeloma treatment."
Phase 2 CARTITUDE-2 study build on previous findings
CARTITUDE-2 cohort A (N=20) enrolled patients with RRMM who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.1 The primary endpoint was minimal residual disease (MRD) negativity.1 Patients from initial cohort A were followed to assess long-term outcomes following a single CARVYKTI(R) infusion without maintenance therapy./1
At a median follow-up of 60.7 months:
- Half of the patients (n=10, 50%) remained alive and progression-free at five years
- The five-year overall survival rate was 69.2%
- Median progression-free survival was 60.5 months
- Patients received a single CARVYKTI(R) infusion without maintenance therapy
At five years, MRD was assessed by bone marrow in three patients and was not required per protocol.1 All three patients were MRD-negative at the deepest level tested (10-6), indicating no detectable disease using highly sensitive testing methods./1
Long-term remissions were observed even among patients with high-risk disease features.1 Of the 10 patients who remained alive and progression-free at five years, five had at least one high-risk cytogenetic abnormality, including four patients with two or more high-risk features./1
The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI(R), with no new CAR T-cell-related neurotoxicity reported.1 Since the previous analysis, one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer./1
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About CARTITUDE-2
CARTITUDE-2 (NCT04133636) is an ongoing, multicohort Phase 2 study evaluating the efficacy and safety of ciltacabtagene autoleucel (CARVYKTI(R)) in patients in different clinical settings, including patients with one to three prior lines of therapy, and continues to generate long-term follow-up data on depth and durability of response. CARTITUDE-2 findings have been presented at major medical congresses, including the International Myeloma Society (IMS) Annual Meeting, and contribute to the growing body of evidence supporting earlier use of CARVYKTI(R) in multiple myeloma.
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About multiple myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.1 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors./2 Multiple myeloma is the third most common blood cancer worldwide./3 More than 180,000 new cases of multiple myeloma are diagnosed globally each year./4 People living with multiple myeloma have a 5-year survival rate of 59.8%.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections./6,7 In recent years, potential overall survival has improved from years to decades for some patients, with effective treatment options now available across every stage and line of therapy./8
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About Johnson & Johnson's multiple myeloma portfolio
Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies.
Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses.
Through ongoing research and a robust clinical program, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured.
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About CARVYKTI(R)
CARVYKTI(R) (cilta-cel) received U.S. Food and Drug Administration approval in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody./9
In April 2024, CARVYKTI(R) was approved in the U.S. for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide, following a unanimous (11 to 0) FDA Oncologic Drugs Advisory Committee (ODAC) recommendation in support of this new indication. In April 2024, the European Medicines Agency (EMA) approved a Type II variation for CARVYKTI(R) for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI(R) for the treatment of adults with relapsed or refractory multiple myeloma in patients that have no history of CAR-positive T cell infusion therapy targeting BCMA and who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In July 2026, CARVYKTI(R) obtained a label expansion in Japan, allowing its use in patients with relapsed or refractory multiple myeloma who have received at least on prior therapy.
CARVYKTI(R) is a BCMA-directed, autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. The CARVYKTI(R) CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells. CARVYKTI(R) is available in 17 markets worldwide and has been used to treat more than 13,000 patients globally.
In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI(R).
For more information, visit www.CARVYKTI.com.
CARVYKTI(R) Important Safety Information
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI(R). Do not administer CARVYKTI(R) to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI(R), including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI(R). Provide supportive care and/or corticosteroids as needed. Parkinsonism and Guillain-Barre syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI(R). Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI(R). HLH/MAS can occur with CRS or neurologic toxicities. Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI(R). Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life threatening reactions, occurred following treatment with CARVYKTI(R). Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI(R). T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI(R).
WARNINGS AND PRECAUTIONS
Increased early mortality. In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI(R) treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI(R) arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI(R) arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI(R) infusion, and 19 deaths occurred after CARVYKTI(R) infusion. Of the 10 deaths that occurred prior to CARVYKTI(R) infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI(R) infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI(R).
Of the 285 patients who received CARVYKTI(R) in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.
Monitor patients at least daily for 7 days following CARVYKTI(R) infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Neurologic toxicities, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI(R). Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.
Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI(R) may experience fatal or life-threatening ICANS following treatment with CARVYKTI(R), including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade 3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.
Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%). Monitor patients at least daily for 7 days following CARVYKTI(R) infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms.
Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.
Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade 3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.
Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson's disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI(R) treatment.
Guillain-Barre syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI(R) despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.
Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.
Immune mediated myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI(R) in CARTITUDE-4 in a patient who received CARVYKTI(R) as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.
Peripheral neuropathy occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade 3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cutoff.
Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.
Cranial nerve palsies occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade 3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).
The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.
Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI(R), with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.
Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI(R).
HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.
Prolonged and Recurrent Cytopenias: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI(R) infusion.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI(R) infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI(R) infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.
Monitor blood counts prior to and after CARVYKTI(R) infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.
Infections: CARVYKTI(R) should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI(R) infusion.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade 3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI(R) had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.
Monitor patients for signs and symptoms of infection before and after CARVYKTI(R) infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI(R) infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.
Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.
Hypogammaglobulinemia can occur in patients receiving treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI(R) for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI(R) and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI(R) treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI(R) treatment, and until immune recovery following treatment with CARVYKTI(R).
Hypersensitivity Reactions occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were 2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.
Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI(R). Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.
Immune effector cell-associated enterocolitis (IEC-EC) has occurred in patients treated with CARVYKTI(R). Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.
In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.
Secondary Malignancies: Patients treated with CARVYKTI(R) may develop secondary malignancies. Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI(R). Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI(R). Mature T-cell malignancies, including CAR positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.
Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.
ADVERSE REACTIONS
The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.
Please read full Prescribing Information (https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf), including Boxed Warning, for CARVYKTI(R).
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About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.jnj.com/innovativemedicine/ Follow us at @JNJInnovMed. Janssen Research & Development, LLC, and Janssen Biotech, Inc., are both Johnson & Johnson companies.
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Caution Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development of CARVYKTI(R) (ciltacabtagene autoleucel; cilta-cel). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory actions; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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Footnote
*/ Niels van de Donk, MD, PhD, Professor of Hematology, University Medical Center, Amsterdam, Netherlands, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
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7/ American Cancer Society. What is multiple myeloma? Accessed September 2026. https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
8/ American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html
9/ Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy. J Clin Oncol. 2018;36(15):1479-1487. https://pmc.ncbi.nlm.nih.gov/articles/PMC6119139/
10/ CARVYKTI(R) U.S. Prescribing Information. 2025. Horsham, PA: Janssen Biotech, Inc.
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Original text here: https://www.jnj.com/media-center/press-releases/single-infusion-of-carvykti-ciltacabtagene-autoleucel-delivered-five-year-treatment-free-remissions-in-50-of-patients-in-early-line-relapsed-refractory-multiple-myeloma
[Category: BizPharmaceuticals]
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Single infusion of CARVYKTI(R) (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma
* New results suggest earlier treatment may increase the likelihood of long-term remission
* Study adds to Johnson & Johnson's overwhelming body of evidence supporting its innovative multiple myeloma therapies in second line, where earlier intervention may increase long-term remission and disease control
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RARITAN, ... Show Full Article RARITAN, New Jersey, Sept. 26 -- Johnson and Johnson Innovative Medicine issued the following news release: * * * Single infusion of CARVYKTI(R) (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma * New results suggest earlier treatment may increase the likelihood of long-term remission * Study adds to Johnson & Johnson's overwhelming body of evidence supporting its innovative multiple myeloma therapies in second line, where earlier intervention may increase long-term remission and disease control - RARITAN,N.J., September 25, 2026 - Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced today new long-term follow-up data from the initial subgroup of cohort A in the Phase 2 CARTITUDE-2 study (N=20) showing that 50% of patients (10/20) in early line relapsed or refractory multiple myeloma (RRMM) who were treated with a single infusion of CARVYKTI(R) (ciltacabtagene autoleucel; cilta-cel) remained alive and progression-free for at least five years without maintenance therapy./1 These results build on the durable, treatment-free remissions observed in the CARTITUDE-1 study, which evaluated patients in later lines of therapy, and reinforce that earlier treatment with CARVYKTI(R) may increase long-term remission and disease control. Together, these findings add to the emerging evidence suggesting that CARVYKTI(R) may have curative potential in some patients.
Findings were presented at the International Myeloma Society (IMS) Annual Meeting (Abstract #PA-288).
Expert and company perspectives on earlier treatment-free remissions with CARVYKTI(R)
"Five years ago, treatment-free remissions of this duration were difficult to imagine for many patients with relapsed or refractory multiple myeloma," said Niels van de Donk, M.D., Ph.D., Professor of Hematology, University Medical Center, Amsterdam, the Netherlands.* "These new CARVYKTI findings provide additional evidence that when highly effective, established therapies are used earlier in the disease course, more patients may have the opportunity to achieve deep, durable remissions and long-term disease control without maintenance."
"These results add to the growing body of evidence suggesting that CARVYKTI may have curative potential for some patients, and reinforce the value of bringing highly effective therapies to patients earlier in their treatment journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "As we continue to advance a portfolio of complementary and combinable therapies, these findings reinforce our commitment to pursuing curative approaches and redefining what patients can expect from multiple myeloma treatment."
Phase 2 CARTITUDE-2 study build on previous findings
CARTITUDE-2 cohort A (N=20) enrolled patients with RRMM who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.1 The primary endpoint was minimal residual disease (MRD) negativity.1 Patients from initial cohort A were followed to assess long-term outcomes following a single CARVYKTI(R) infusion without maintenance therapy./1
At a median follow-up of 60.7 months:
- Half of the patients (n=10, 50%) remained alive and progression-free at five years
- The five-year overall survival rate was 69.2%
- Median progression-free survival was 60.5 months
- Patients received a single CARVYKTI(R) infusion without maintenance therapy
At five years, MRD was assessed by bone marrow in three patients and was not required per protocol.1 All three patients were MRD-negative at the deepest level tested (10-6), indicating no detectable disease using highly sensitive testing methods./1
Long-term remissions were observed even among patients with high-risk disease features.1 Of the 10 patients who remained alive and progression-free at five years, five had at least one high-risk cytogenetic abnormality, including four patients with two or more high-risk features./1
The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI(R), with no new CAR T-cell-related neurotoxicity reported.1 Since the previous analysis, one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer./1
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About CARTITUDE-2
CARTITUDE-2 (NCT04133636) is an ongoing, multicohort Phase 2 study evaluating the efficacy and safety of ciltacabtagene autoleucel (CARVYKTI(R)) in patients in different clinical settings, including patients with one to three prior lines of therapy, and continues to generate long-term follow-up data on depth and durability of response. CARTITUDE-2 findings have been presented at major medical congresses, including the International Myeloma Society (IMS) Annual Meeting, and contribute to the growing body of evidence supporting earlier use of CARVYKTI(R) in multiple myeloma.
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About multiple myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.1 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors./2 Multiple myeloma is the third most common blood cancer worldwide./3 More than 180,000 new cases of multiple myeloma are diagnosed globally each year./4 People living with multiple myeloma have a 5-year survival rate of 59.8%.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections./6,7 In recent years, potential overall survival has improved from years to decades for some patients, with effective treatment options now available across every stage and line of therapy./8
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About Johnson & Johnson's multiple myeloma portfolio
Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies.
Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses.
Through ongoing research and a robust clinical program, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured.
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About CARVYKTI(R)
CARVYKTI(R) (cilta-cel) received U.S. Food and Drug Administration approval in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody./9
In April 2024, CARVYKTI(R) was approved in the U.S. for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide, following a unanimous (11 to 0) FDA Oncologic Drugs Advisory Committee (ODAC) recommendation in support of this new indication. In April 2024, the European Medicines Agency (EMA) approved a Type II variation for CARVYKTI(R) for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI(R) for the treatment of adults with relapsed or refractory multiple myeloma in patients that have no history of CAR-positive T cell infusion therapy targeting BCMA and who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In July 2026, CARVYKTI(R) obtained a label expansion in Japan, allowing its use in patients with relapsed or refractory multiple myeloma who have received at least on prior therapy.
CARVYKTI(R) is a BCMA-directed, autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. The CARVYKTI(R) CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells. CARVYKTI(R) is available in 17 markets worldwide and has been used to treat more than 13,000 patients globally.
In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI(R).
For more information, visit www.CARVYKTI.com.
CARVYKTI(R) Important Safety Information
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI(R). Do not administer CARVYKTI(R) to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI(R), including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI(R). Provide supportive care and/or corticosteroids as needed. Parkinsonism and Guillain-Barre syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI(R). Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI(R). HLH/MAS can occur with CRS or neurologic toxicities. Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI(R). Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life threatening reactions, occurred following treatment with CARVYKTI(R). Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI(R). T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI(R).
WARNINGS AND PRECAUTIONS
Increased early mortality. In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI(R) treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI(R) arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI(R) arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI(R) infusion, and 19 deaths occurred after CARVYKTI(R) infusion. Of the 10 deaths that occurred prior to CARVYKTI(R) infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI(R) infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI(R).
Of the 285 patients who received CARVYKTI(R) in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.
Monitor patients at least daily for 7 days following CARVYKTI(R) infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Neurologic toxicities, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI(R). Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.
Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI(R) may experience fatal or life-threatening ICANS following treatment with CARVYKTI(R), including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade 3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.
Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%). Monitor patients at least daily for 7 days following CARVYKTI(R) infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms.
Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.
Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade 3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.
Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson's disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI(R) treatment.
Guillain-Barre syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI(R) despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.
Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.
Immune mediated myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI(R) in CARTITUDE-4 in a patient who received CARVYKTI(R) as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.
Peripheral neuropathy occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade 3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cutoff.
Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.
Cranial nerve palsies occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade 3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).
The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.
Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI(R), with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.
Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI(R).
HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.
Prolonged and Recurrent Cytopenias: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI(R) infusion.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI(R) infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI(R) infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.
Monitor blood counts prior to and after CARVYKTI(R) infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.
Infections: CARVYKTI(R) should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI(R) infusion.
Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade 3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI(R) had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.
Monitor patients for signs and symptoms of infection before and after CARVYKTI(R) infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI(R) infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.
Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.
Hypogammaglobulinemia can occur in patients receiving treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI(R) for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI(R) and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI(R) treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI(R) treatment, and until immune recovery following treatment with CARVYKTI(R).
Hypersensitivity Reactions occurred following treatment with CARVYKTI(R). Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were 2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.
Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI(R). Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.
Immune effector cell-associated enterocolitis (IEC-EC) has occurred in patients treated with CARVYKTI(R). Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.
In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.
Secondary Malignancies: Patients treated with CARVYKTI(R) may develop secondary malignancies. Among patients receiving CARVYKTI(R) in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI(R). Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI(R). Mature T-cell malignancies, including CAR positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.
Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.
ADVERSE REACTIONS
The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.
Please read full Prescribing Information (https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf), including Boxed Warning, for CARVYKTI(R).
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About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.jnj.com/innovativemedicine/ Follow us at @JNJInnovMed. Janssen Research & Development, LLC, and Janssen Biotech, Inc., are both Johnson & Johnson companies.
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Caution Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development of CARVYKTI(R) (ciltacabtagene autoleucel; cilta-cel). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory actions; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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Footnote
*/ Niels van de Donk, MD, PhD, Professor of Hematology, University Medical Center, Amsterdam, Netherlands, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
1/ Cohen A, et al. Long-Term (5-Year) Remission and Survival With Ciltacabtagene Autoleucel (Cilta-Cel) in Relapsed/Refractory Multiple Myeloma (RRMM) With 1 to 3 Prior Lines of Therapy: CARTITUDE-2 Cohort A. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 25, 2026; Glasgow, Sweden.
2/ Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-567.
3/ National Cancer Institute. Plasma cell neoplasms. Accessed September 2026. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq
4/ City of Hope. Multiple myeloma: Causes, symptoms & treatments. 2022. Accessed September 2026. https://www.cancercenter.com/cancer-types/multiple-myeloma
5/ International Agency for Research on Cancer (World Health Organization). Multiple myeloma fact sheet. 2024. Accessed September 2026. https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf
6/ SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. Accessed September 2026. https://seer.cancer.gov/explorer/
7/ American Cancer Society. What is multiple myeloma? Accessed September 2026. https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
8/ American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html
9/ Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy. J Clin Oncol. 2018;36(15):1479-1487. https://pmc.ncbi.nlm.nih.gov/articles/PMC6119139/
10/ CARVYKTI(R) U.S. Prescribing Information. 2025. Horsham, PA: Janssen Biotech, Inc.
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Original text here: https://www.jnj.com/media-center/press-releases/single-infusion-of-carvykti-ciltacabtagene-autoleucel-delivered-five-year-treatment-free-remissions-in-50-of-patients-in-early-line-relapsed-refractory-multiple-myeloma
[Category: BizPharmaceuticals]
Jackson Walker: Robert Soza to Receive 2026 C. Lee Cusenbary Ethical Life and Leadership Award
AUSTIN, Texas, Sept. 26 -- Jackson Walker, a law firm, issued the following news:
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Robert Soza to Receive 2026 C. Lee Cusenbary Ethical Life and Leadership Award
September 25, 2026
Jackson Walker partner Robert L. Soza Jr. has been named a recipient of the 2026 C. Lee Cusenbary Ethical Life and Leadership Award by the Association of Corporate Counsel's San Antonio Chapter and The Texas Lawbook.
The award honors one in-house lawyer or legal department and one private lawyer or law firm each year for exceptional ethical conduct and leadership in the practice of law.
Robert was nominated ... Show Full Article AUSTIN, Texas, Sept. 26 -- Jackson Walker, a law firm, issued the following news: * * * Robert Soza to Receive 2026 C. Lee Cusenbary Ethical Life and Leadership Award September 25, 2026 Jackson Walker partner Robert L. Soza Jr. has been named a recipient of the 2026 C. Lee Cusenbary Ethical Life and Leadership Award by the Association of Corporate Counsel's San Antonio Chapter and The Texas Lawbook. The award honors one in-house lawyer or legal department and one private lawyer or law firm each year for exceptional ethical conduct and leadership in the practice of law. Robert was nominatedby Julia W. Mann, managing partner of Jackson Walker's San Antonio office, who cited his professional excellence, principled leadership, sustained mentorship, and longstanding service to the community.
He will receive the honor alongside Vericast Deputy General Counsel Shelayne Clemmer at the 2026 San Antonio Corporate Counsel Awards on October 29.
To read the full The Texas Lawbook article, visit Vericast Deputy GC, Jackson Walker Partner Honored for Ethical Life, Leadership (https://texaslawbook.net/vericast-deputy-gc-jackson-walker-partner-honored-for-ethical-life-leadership/).
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Meet Robert
Robert L. Soza Jr. is a seasoned attorney based in San Antonio with deep experience in international trade compliance and complex litigation. A licensed U.S. Customs Broker, he advises clients on FCPA, anti-corruption, anti-money laundering, export controls, trade sanctions, CFIUS, and U.S. Customs compliance--handling audits, enforcement counseling, voluntary disclosures, and government proceedings before agencies including the Departments of Commerce, State, and Treasury. He also brings significant first-chair trial and appellate experience in environmental, personal injury, and civil enforcement matters, having litigated cases across Texas, New Mexico, Colorado, Kansas, California, and New York.
Robert is a recognized leader in both his profession and his community. He received the President's Award from the San Antonio Bar Association in 2019, is a San Antonio Bar Foundation Fellow, and currently serves as President of the Board of Directors of the San Antonio Legal Services Association (SALSA). He has been named to Chambers USA, The Best Lawyers in America, Thomson Reuters' Super Lawyers, and Lawdragon's list of the 500 Leading Litigators in America.
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Original text here: https://www.jw.com/news/soza-ethical-life-leadership-award/
[Category: BiLaw/Legal]
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Robert Soza to Receive 2026 C. Lee Cusenbary Ethical Life and Leadership Award
September 25, 2026
Jackson Walker partner Robert L. Soza Jr. has been named a recipient of the 2026 C. Lee Cusenbary Ethical Life and Leadership Award by the Association of Corporate Counsel's San Antonio Chapter and The Texas Lawbook.
The award honors one in-house lawyer or legal department and one private lawyer or law firm each year for exceptional ethical conduct and leadership in the practice of law.
Robert was nominated ... Show Full Article AUSTIN, Texas, Sept. 26 -- Jackson Walker, a law firm, issued the following news: * * * Robert Soza to Receive 2026 C. Lee Cusenbary Ethical Life and Leadership Award September 25, 2026 Jackson Walker partner Robert L. Soza Jr. has been named a recipient of the 2026 C. Lee Cusenbary Ethical Life and Leadership Award by the Association of Corporate Counsel's San Antonio Chapter and The Texas Lawbook. The award honors one in-house lawyer or legal department and one private lawyer or law firm each year for exceptional ethical conduct and leadership in the practice of law. Robert was nominatedby Julia W. Mann, managing partner of Jackson Walker's San Antonio office, who cited his professional excellence, principled leadership, sustained mentorship, and longstanding service to the community.
He will receive the honor alongside Vericast Deputy General Counsel Shelayne Clemmer at the 2026 San Antonio Corporate Counsel Awards on October 29.
To read the full The Texas Lawbook article, visit Vericast Deputy GC, Jackson Walker Partner Honored for Ethical Life, Leadership (https://texaslawbook.net/vericast-deputy-gc-jackson-walker-partner-honored-for-ethical-life-leadership/).
* * *
Meet Robert
Robert L. Soza Jr. is a seasoned attorney based in San Antonio with deep experience in international trade compliance and complex litigation. A licensed U.S. Customs Broker, he advises clients on FCPA, anti-corruption, anti-money laundering, export controls, trade sanctions, CFIUS, and U.S. Customs compliance--handling audits, enforcement counseling, voluntary disclosures, and government proceedings before agencies including the Departments of Commerce, State, and Treasury. He also brings significant first-chair trial and appellate experience in environmental, personal injury, and civil enforcement matters, having litigated cases across Texas, New Mexico, Colorado, Kansas, California, and New York.
Robert is a recognized leader in both his profession and his community. He received the President's Award from the San Antonio Bar Association in 2019, is a San Antonio Bar Foundation Fellow, and currently serves as President of the Board of Directors of the San Antonio Legal Services Association (SALSA). He has been named to Chambers USA, The Best Lawyers in America, Thomson Reuters' Super Lawyers, and Lawdragon's list of the 500 Leading Litigators in America.
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Original text here: https://www.jw.com/news/soza-ethical-life-leadership-award/
[Category: BiLaw/Legal]
AstraZeneca: Perioperative Imfinzi Plus Neoadjuvant Enfortumab Vedotin Granted Priority Review in the US for Patients With Muscle-invasive Bladder Cancer
WILMINGTON, Delaware, Sept. 26 -- AstraZeneca, a biopharmaceutical company, issued the following news release:
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Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer
25 September 2026
Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival
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AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV) ... Show Full Article WILMINGTON, Delaware, Sept. 26 -- AstraZeneca, a biopharmaceutical company, issued the following news release: * * * Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer 25 September 2026 Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival - AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV)has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance./1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is anticipated during the fourth quarter of 2026.
Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumor invades the muscle wall of the bladder, without distant metastases./2,3 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities./4,5 The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis./4-6
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This Priority Review reinforces the potential of IMFINZI to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting."
The sBLA is based on results from the VOLGA Phase III trial, which will be presented at a forthcoming medical meeting. In a planned interim analysis, perioperative treatment with IMFINZI in combination with neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) versus radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.
The safety and tolerability of IMFINZI plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.
Regulatory applications are currently under review in the EU, Japan and several other countries based on the results of the VOLGA trial.
IMFINZI is approved in over 50 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. IMFINZI in combination with Bacillus Calmette-Guerin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naive, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial. In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.
IMPORTANT SAFETY INFORMATION
There are no contraindications for IMFINZI(R) (durvalumab) or IMJUDO(R) (tremelimumab-actl).
Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
* IMFINZI as a Single Agent
- In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.
- In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.
- The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.
- The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
* IMFINZI with IMJUDO
- Immune mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
Immune-Mediated Colitis
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
* IMFINZI as a Single Agent
- Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.
Immune-Mediated Hepatitis
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.
* IMFINZI as a Single Agent
- Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.
Immune-Mediated Endocrinopathies
* Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
* Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
- IMFINZI with IMJUDO
= Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
* Thyroid Disorders: IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
= Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
= Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.
= Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.
= Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
- IMFINZI with Carboplatin and Paclitaxel
= Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
* Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
- IMFINZI with IMJUDO
= Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI and IMJUDO can cause immune-mediated nephritis.
* IMFINZI as a Single Agent
- Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-Mediated Dermatology Reactions
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
* IMFINZI as a Single Agent
- Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.
* Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
* Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.
* Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
* Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
* Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
* Endocrine: Hypoparathyroidism.
* Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.
* Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
* IMFINZI as a Single Agent
- Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
* IMFINZI with IMJUDO
- Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.
Lactation
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.
Adverse Reactions
Unresectable Stage III NSCLC
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.
Resectable NSCLC
* In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in 20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
* In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.
* In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.
Metastatic NSCLC
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in 20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.
Limited-stage Small Cell Lung Cancer
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in 20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonitis or radiation pneumonitis and pneumonia.
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in 1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).
Extensive-stage Small Cell Lung Cancer
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (3%) was fatigue/asthenia (3.4%).
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.
Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in 20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).
Unresectable Hepatocellular Carcinoma (HCC)
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in 20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.
Primary Advanced or Recurrent dMMR Endometrial Cancer
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (3%) were constipation (4.5%) and fatigue (4.5%).
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (4%) were constipation (4.5%) and rash (4.5%).
BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).
Muscle-Invasive Bladder Cancer (MIBC)
* In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in 20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.
* In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.
* In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in 1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).
Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)
* In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in 20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
* In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of 2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of 2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of 2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.
Indications:
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.
IMFINZI in combination with Bacillus Calmette-Guerin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Please see Full Prescribing Information including Medication Guide for IMFINZI (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9496217c-08b3-432b-ab4f-538d795820bd/9496217c-08b3-432b-ab4f-538d795820bd_viewable_rendition__v.pdf) and IMJUDO (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/0102c6fd-de8a-4b43-afa3-2a2c2115d472/0102c6fd-de8a-4b43-afa3-2a2c2115d472_viewable_rendition__v.pdf).
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Notes
Bladder cancer
Bladder cancer is the 8th most common cancer in the world, with more than 635,000 cases diagnosed each year.7 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.8
In 2026, around 15,000 patients will be treated for MIBC in the United States.9 In 2025, the NIAGARA Phase III trial established a new standard of care by adding perioperative IMFINZI to neoadjuvant cisplatin-based chemotherapy and radical cystectomy.10 However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence.4,6 New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.
VOLGA
VOLGA is a Phase III, randomized, open-label, multi-center global trial evaluating perioperative IMFINZI with or without IMJUDO in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are not eligible for or have declined cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomized 1:1:1 to Arm 1 (three cycles of IMFINZI and EV, plus two cycles of IMJUDO prior to surgery, followed by nine cycles of IMFINZI plus one cycle of IMJUDO as adjuvant therapy), Arm 2 (three cycles of IMFINZI and EV prior to surgery, followed by nine cycles of IMFINZI adjuvant monotherapy) and Arm 3, the comparator arm.
The trial was conducted in 182 centers across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomization to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.
IMFINZI(R) (durvalumab)
IMFINZI(R) (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
In addition to its bladder cancer indications, IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO(R) (tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC. IMFINZI is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.
IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US, EU and Japan. Additionally, in April 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone for patients with unresectable HCC eligible for embolization in the EMERALD-3 Phase III trial.
IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US, EU and China). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.
Since the first approval in May 2017, more than 470,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.
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AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body's immune system to attack tumors.
AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
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AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
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AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.
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References
1. FDA. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed September 2026.
2. Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer. Eur Urol. 2013;63(2):234-241.
3. National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289/. Accessed September 2026.
4. Dash A, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506-513.
5. Galsky MD, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.
6. Holzbeierlein J, Bixler BR, Buckley DI, Chang SS, Holmes RS, James AC, et al. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO Guideline (2017; Amended 2020, 2024). J Urology [Internet]. 2024 Jul 1 [cited 2026 Sep 3];212(1):3-10. Available from: https://doi.org/10.1097/JU.0000000000003981.
7. World Health Organization. International Agency for Research on Cancer. Bladder Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. Accessed September 2026.
8. American Cancer Society. What Is Bladder Cancer? Available at: https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html. Accessed September 2026.
9. AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed September 2026.
10. AstraZeneca PLC. Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html. Accessed September 2026.
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Original text here: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Perioperative-IMFINZI-durvalumab-plus-neoadjuvant-enfortumab-vedotin-granted-Priority-Review-in-the-US-for-patients-with-muscle-invasive-bladder-cancer.html
[Category: BizPharmaceuticals]
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Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer
25 September 2026
Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival
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AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV) ... Show Full Article WILMINGTON, Delaware, Sept. 26 -- AstraZeneca, a biopharmaceutical company, issued the following news release: * * * Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer 25 September 2026 Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival - AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV)has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance./1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is anticipated during the fourth quarter of 2026.
Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumor invades the muscle wall of the bladder, without distant metastases./2,3 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities./4,5 The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis./4-6
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This Priority Review reinforces the potential of IMFINZI to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting."
The sBLA is based on results from the VOLGA Phase III trial, which will be presented at a forthcoming medical meeting. In a planned interim analysis, perioperative treatment with IMFINZI in combination with neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) versus radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.
The safety and tolerability of IMFINZI plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.
Regulatory applications are currently under review in the EU, Japan and several other countries based on the results of the VOLGA trial.
IMFINZI is approved in over 50 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. IMFINZI in combination with Bacillus Calmette-Guerin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naive, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial. In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.
IMPORTANT SAFETY INFORMATION
There are no contraindications for IMFINZI(R) (durvalumab) or IMJUDO(R) (tremelimumab-actl).
Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
* IMFINZI as a Single Agent
- In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.
- In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.
- The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.
- The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
* IMFINZI with IMJUDO
- Immune mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
Immune-Mediated Colitis
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
* IMFINZI as a Single Agent
- Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.
Immune-Mediated Hepatitis
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.
* IMFINZI as a Single Agent
- Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.
Immune-Mediated Endocrinopathies
* Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
* Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
- IMFINZI with IMJUDO
= Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
* Thyroid Disorders: IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
= Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
= Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.
= Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.
= Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
- IMFINZI with Carboplatin and Paclitaxel
= Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
* Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
- IMFINZI with IMJUDO
= Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI and IMJUDO can cause immune-mediated nephritis.
* IMFINZI as a Single Agent
- Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-Mediated Dermatology Reactions
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
* IMFINZI as a Single Agent
- Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.
* Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
* Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.
* Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
* Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
* Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
* Endocrine: Hypoparathyroidism.
* Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.
* Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
* IMFINZI as a Single Agent
- Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
* IMFINZI with IMJUDO
- Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.
Lactation
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.
Adverse Reactions
Unresectable Stage III NSCLC
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.
Resectable NSCLC
* In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in 20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
* In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.
* In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.
Metastatic NSCLC
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in 20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.
Limited-stage Small Cell Lung Cancer
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in 20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonitis or radiation pneumonitis and pneumonia.
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in 1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).
Extensive-stage Small Cell Lung Cancer
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (3%) was fatigue/asthenia (3.4%).
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.
Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in 20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).
Unresectable Hepatocellular Carcinoma (HCC)
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in 20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.
Primary Advanced or Recurrent dMMR Endometrial Cancer
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (3%) were constipation (4.5%) and fatigue (4.5%).
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (4%) were constipation (4.5%) and rash (4.5%).
BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).
Muscle-Invasive Bladder Cancer (MIBC)
* In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in 20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.
* In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.
* In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in 1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).
Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)
* In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in 20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
* In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of 2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of 2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of 2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.
Indications:
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.
IMFINZI in combination with Bacillus Calmette-Guerin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Please see Full Prescribing Information including Medication Guide for IMFINZI (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9496217c-08b3-432b-ab4f-538d795820bd/9496217c-08b3-432b-ab4f-538d795820bd_viewable_rendition__v.pdf) and IMJUDO (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/0102c6fd-de8a-4b43-afa3-2a2c2115d472/0102c6fd-de8a-4b43-afa3-2a2c2115d472_viewable_rendition__v.pdf).
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Notes
Bladder cancer
Bladder cancer is the 8th most common cancer in the world, with more than 635,000 cases diagnosed each year.7 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.8
In 2026, around 15,000 patients will be treated for MIBC in the United States.9 In 2025, the NIAGARA Phase III trial established a new standard of care by adding perioperative IMFINZI to neoadjuvant cisplatin-based chemotherapy and radical cystectomy.10 However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence.4,6 New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.
VOLGA
VOLGA is a Phase III, randomized, open-label, multi-center global trial evaluating perioperative IMFINZI with or without IMJUDO in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are not eligible for or have declined cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomized 1:1:1 to Arm 1 (three cycles of IMFINZI and EV, plus two cycles of IMJUDO prior to surgery, followed by nine cycles of IMFINZI plus one cycle of IMJUDO as adjuvant therapy), Arm 2 (three cycles of IMFINZI and EV prior to surgery, followed by nine cycles of IMFINZI adjuvant monotherapy) and Arm 3, the comparator arm.
The trial was conducted in 182 centers across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomization to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.
IMFINZI(R) (durvalumab)
IMFINZI(R) (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
In addition to its bladder cancer indications, IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO(R) (tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC. IMFINZI is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.
IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US, EU and Japan. Additionally, in April 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone for patients with unresectable HCC eligible for embolization in the EMERALD-3 Phase III trial.
IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US, EU and China). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.
Since the first approval in May 2017, more than 470,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.
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AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body's immune system to attack tumors.
AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
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AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
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AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.
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References
1. FDA. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed September 2026.
2. Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer. Eur Urol. 2013;63(2):234-241.
3. National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289/. Accessed September 2026.
4. Dash A, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506-513.
5. Galsky MD, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.
6. Holzbeierlein J, Bixler BR, Buckley DI, Chang SS, Holmes RS, James AC, et al. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO Guideline (2017; Amended 2020, 2024). J Urology [Internet]. 2024 Jul 1 [cited 2026 Sep 3];212(1):3-10. Available from: https://doi.org/10.1097/JU.0000000000003981.
7. World Health Organization. International Agency for Research on Cancer. Bladder Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. Accessed September 2026.
8. American Cancer Society. What Is Bladder Cancer? Available at: https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html. Accessed September 2026.
9. AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed September 2026.
10. AstraZeneca PLC. Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html. Accessed September 2026.
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Original text here: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Perioperative-IMFINZI-durvalumab-plus-neoadjuvant-enfortumab-vedotin-granted-Priority-Review-in-the-US-for-patients-with-muscle-invasive-bladder-cancer.html
[Category: BizPharmaceuticals]