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2021-06-29| R&DTrials & Approvals

Gilead’s CAR-T Drug Outperforms Standard of Care in B-Cell Lymphoma Trial

by Daniel Ojeda
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On June 28th, Kite, a company of Gilead, announced that Yescarta, a CAR-T therapy improved event-free survival when compared with second-line standard of care therapy in relapsed or refractory large B-cell lymphoma. Yescarta is currently approved as third-line therapy, but the topline results move it closer to becoming a first- and second-line therapy for lymphoma.

CAR-T therapies involve modifying the patient’s own T-cells in the laboratory to express a chimeric antigen receptor. These modified immune cells kill B lymphocytes and can stimulate the immune system. Yescarta is one of three CAR-T therapies FDA-approved as a third-line treatment of large B-cell lymphoma.

 

Phase 3 ZUMA-7 Trial

The safety and efficacy of Yescarta were tested on the randomized, open-label, global, multicenter, Phase 3 clinical trial. The trial compared the efficacy of Yescarta as a second-line treatment versus the current SOC, which consists of two steps: 1) Reintroduction of immunochemotherapy and 2) high-dose therapy and stem cell transplantation.

The analysis shows that Yescarta improved event-free survival, defined as the time from enrollment to clinical trial to the earliest date of disease progression, by 60%. Yescarta also improved the objective response rate. Additionally, the interim analysis shows Yescarta may significantly improve overall survival. However, further analysis is necessary to determine if the trend is maintained.

Kite also announced it would begin talks with the FDA and other global health authorities to expand Yescarta’s indications.

“Yescarta has been instrumental in transforming outcomes for patients with third-line LBCL. Our goal has always been to bring the benefit of CAR T-cell therapy to more patients, earlier in their treatment, where the potential for benefit may be even greater,” said Kite CEO Christi Shaw.

“As the leader in cell therapy, Kite is honored to deliver this landmark study and would like to thank the patients, families, physicians, and care teams around the world that made this possible.”

 

Closest Competitors

Apart from Yescarta, two more CAR-T therapies are FDA-approved as third-line therapies for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These are:

  1. Kymriah, developed by Novartis and the first CAR-T therapy to receive FDA approval for DLCLB. It is currently conducting clinical trials in other lymphomas.
  2. Breyanzi, developed by Bristol-Myers Squibb. It is the most recent CAR T therapy to receive FDA approval. It just completed a Phase 3 trial as second-line therapy for DLBCL.

All these therapies consist of a modified CD-19 chimeric antigen receptor, but they have different costimulatory domains. However, Yescarta’s main competitor is Breyanzi. Just a few weeks ago, it announced the interim results of its Phase 3 clinical trial. Breyanzi also significantly improved event-free survival when compared with the current SOC. It is now a race to become a first-line therapy and the SOC at different levels of treatment.

Related Article: Gilead’s Yescarta Becomes First CAR-T Therapy to Score Regulatory Approval in China

 

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