Tag Archives: 2L DLBCL

The Race to 2L DLBCL: Breyanzi’s Ph3 TRANSFORM Trial vs Yescarta’s Ph3 ZUMA-7 Study; Can BMS Shift Toward Outpatient CD19 CAR-T Administration? ASH 2021 Day 1 Part 2

On the first and second day of ASH 2021, 4 clinical updates were presented by BMS and Gilead (Kite) including Breyanzi’s (CD19 CAR-T) and Yescarta’s (CD19 CAR-T) efficacy and safety profiles in 2L DLBCL. Moreover, BMS commented on the feasibility of administering Breyanzi in the outpatient setting. Below, Celltelligence provides insights and context for each presentation.

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Gilead Files an sBLA for Yescarta in 2L R/R DLBCL

On Thursday, September 30, Gilead (Kite) announced (press release) that they have submitted an sBLA to the FDA for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Of note, Yescarta’s sBLA application is supported by data from the Ph3 ZUMA-7 trial in 2L r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s estimated FDA approval timeline for 2L r/r DLBCL, while discussing how Breyanzi (BMS) and Kymriah (Novartis) compare in the 2L setting.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Thoughts on Novartis’s Ph3 BELINDA Trial Failure; Will Novartis Continue Pursuing Kymriah in the 2L DLBCL Setting?

Recently, Novartis reported (press release) that their Ph3 BELINDA study evaluating Kymriah (CD19 CAR-T) in 2L NHL did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis’s trial design could have potentially contributed to BELINDA’s failure, while discussing alternative approaches that Novartis may take to stay in the 2L DLBCL setting.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Novartis’s Ph3 BELINDA Trial Fails in 2L NHL; All Eyes on 2L Positive Data for Yescarta and Breyanzi

On Tuesday, August 24, Novartis announced (press release) an update on Kymriah’s (CD19 CAR-T) Ph3 BELINDA trial in 2L NHL. Of note, the BELINDA study did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis could use this opportunity to accelerate Kymriah’s indication in r/r FL, while prioritizing their more novel next-generation CAR-T programs.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Gilead’s Ph3 ZUMA-7 Trial Demonstrates Improved Efficacy of Yescarta vs SoC in 2L DLBCL; Which CD19 CAR-T Treating DLBCL Will Move Into an Earlier Line of Therapy First? First Patient Dosed With Precision’s PBCAR269A + Nirogacestat Combination

On Monday, June 28, Gilead (Kite) reported (press release) topline results from the primary analysis of Yescarta (CD19 CAR-T) vs the SoC in the Ph3 ZUMA-7 trial for 2L r/r DLBCL patients. Furthermore, Precision BioSciences and SpringWorks announced (press release) that the first patient has been dosed with PBCAR269A (BCMA CAR-T) + nirogacestat (GSI) in the Ph1/2a trial for r/r MM patients. Below, Celltelligence provides insights on how Yescarta’s potential approval timeline in 2L DLBCL compares with key competitors Kymriah (Novartis) and Breyanzi (BMS) while discussing Precision’s and key competitor Allogene’s clinical progress combining a GSI with their lead BCMA CAR-T assets.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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