Tag Archives: ZUMA-7

Francesco Marincola Departs Kite as Head of Cell Therapy Research; Yescarta Significantly Improved OS in 2L LBCL

On Tuesday, March 21, Sonata Therapeutics announced (press release) the CSO appointment of Francesco Marincola, former SVP and Global Head of Cell Therapy Research at Gilead (Kite). On the same day, Gilead (Kite) reported (press release) the primary overall survival (OS) data analysis of Yescarta’s (autologous CD19 CAR-T) Ph3 ZUMA-7 trial in 2L DLBCL demonstrating a significant OS improvement for Yescarta versus SOC. Below, Celltelligence provides insights on Marincola’s departure from Kite, while discussing how OS data could further support Yescarta’s leading position in the market.

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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 Reports Outstanding Cell Therapy Revenue Growth; Yescarta’s Manufacturing Capacity Scaled to Address Demand; Updated Regulatory Milestones for Yescarta and Tecartus in the EU; Gilead’s Q2 2022 Earnings Call Summary

On Tuesday, August 2, Gilead (Kite) held their Q2 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing EU regulatory milestones for Yescarta and Tecartus (CD19 CAR-Ts). Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how Gilead’s manufacturing strategy could accommodate Yescarta’s expected increase in demand.

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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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Initial Data from Yescarta’s Ph2 ZUMA-14 Study for R/R LBCL in Combination with Rituximab; Updated Results for Tecartus in ALL and MCL; ASCO 2022 Analysis 2

ASCO 2022 Analysis 2: Gilead (Kite) reported updated clinical data in LBCL, MCL, and adult B-ALL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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The Race Continues in the 2L LBCL Setting; BMS and Gilead Provide Clinical Updates for Breyanzi and Yescarta; ASCO 2022 Analysis 1

ASCO 2022 Analysis 1: Gilead (Kite) and BMS presented clinical data updates in 2L LBCL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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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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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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Yescarta’s Sales Decline; Gilead’s (Kite) New Manufacturing Facility in Maryland to Be Operational By Mid-2022; Health Canada Approves Tecartus in MCL; Gilead’s Q3 2021 Earnings Call Summary

On Thursday, October 28, Gilead held their Q3 2021 earnings call (press release / presentation) highlighting Yescarta’s (CD19 CAR-T) sales decline and the anticipated opening of their new manufacturing facility in Frederick County, Maryland. On the same day, Gilead announced (press release) that Health Canada has approved Tecartus (CD19 CAR-T) in r/r mantle cell lymphoma (MCL), based on results from the Ph2 ZUMA-2 trial. Below, Celltelligence provides insights on the potential impact of increased ATC competition on Yescarta’s Q3 sales revenue, while outlining likely US and EU approval timelines for Yescarta in 2L r/r DLBCL and Tecartus in r/r adult ALL. Finally, Celltelligence discusses Tecartus’s approval and reimbursement in Canada.

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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 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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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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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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