Tag Archives: ZUMA-5

Gilead, Novartis, and BMS Report Follow-up Data from Approved Lymphoma Therapies; ASH 2022 Analysis 6

ASH 2022 Analysis 6: Gilead (Kite), Novartis, and BMS and presented follow-up data from various clinical trials in lymphoma. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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The EC Grants Yescarta Marketing Authorization for ≥4L R/R FL

On Tuesday, June 28, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Yescarta (CD19 CAR-T) in ≥4L r/r FL. Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Kymriah (Novartis’s CD19 CAR-T).

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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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Could Autolus’s AUTO1/22 Novel CD22 Binder Avoid Antigen-Related Relapse in ALL? Updated Results from Cellectis’s UCART22 Ph1 BALLI-01 Trial; Yescarta’s Ph2 ZUMA-5 Trial Continues to Demonstrate Positive Long-Term Results; ASH 2021 Day 1 Part 1

On the first day of ASH 2021, 3 clinical updates were presented by Autolus, Cellectis, and Gilead. Below, Celltelligence provides insights and context for each presentation. In a subsequent blast, the Celltelligence team will provide insights from Precision’s PBCAR0191 (allogeneic CD19 CAR-T) clinical update and results from both Ph3 2L DLBCL studies from BMS (Breyanzi; CD19 CAR-T) and Gilead (Yescarta; CD19 CAR-T).

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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 Outperforms SoC in a Matched Analysis of ZUMA-5 in r/r FL; Tecartus’s Improved Safety Profile in the Ph1/2 ZUMA-4 Trial; Breyanzi’s Ph2 OUTREACH Trial Demonstrates the Feasibility of Outpatient Administration; Obe-cel Reports a Possible Best-in-Class Profile for Adult ALL; Mustang Bio’s MB-106 Reports a 93% ORR in NHL; EHA 2021 Day 3

On the last day of EHA 2021, five key clinical updates were presented from Gilead (Kite), BMS, Autolus, and Mustang Bio. 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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Results from Kymriah’s Ph2 ELARA Trial; When Could Kymriah Become Approved in FL? Is Retreatment With Yescarta Commercially Feasible? CBMG Highlights Results From C-CAR066 and C-CAR039; ASCO 2021 Day 3 Part II

On the third day of ASCO 2021, five key clinical updates were presented from Novartis, Gilead, and CBMG. Below, Celltelligence provides insights and context for each presentation.

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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 Reports Innovative Biomarkers Associated with Clinical Outcomes in the Ph2 ZUMA-5 Trial; Carl June Explores Novel Approaches to Improve CAR-T Function; IL-2 Makes a Comeback with OrthoCARs; AACR 2021 Day 3

On the third day of AACR 2021 Week I, key clinical / preclinical updates were reported from Gilead (Kite) and Synthekine, while Carl June presented an overview of CAR-T engineering tools to improve efficacy and safety outcomes. Below, Celltelligence provides insights and context for each presentation.

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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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Yescarta Receives Broader FL Label Than Breyanzi; MZL Not Granted in Yescarta’s ZUMA-5 Accelerated Approval

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated approvals and submissions following Gilead’s (Kite) announcement (see below for download).

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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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Thoughts on Gilead’s sBLA Submission for Yescarta in r/r iNHL (ZUMA-5)

On Friday, September 4, Gilead announced (press release) the submission of an sBLA to the FDA for Yescarta in r/r ≥3L iNHL (follicular lymphoma and marginal zone lymphoma). The sBLA application is based upon positive results from the Ph2 ZUMA-5 trial. Below, Celltelligence provides insights on Yescarta’s sBLA timeline and the potential impact from competitors Novartis (Kymriah) and BMS (liso-cel).

About The Author

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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