FDA Approves Label Update for Gilead's Kite CAR T-Cell Therapy Yescarta to Include Overall Survival Data from ZUMA-7 Trial

Dec 26, 2023 10:24 CST Updated 10:24

Kite Pharma

CAR-T Cell Immunotherapy R&D Provider

Gilead Sciences

Antiviral Drug Developer

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On December 21, 2023, Kite, a subsidiary of Gilead Sciences, announced that the U.S. Food and Drug Administration (FDA) has approved Yescarta®.（axicabtagene ciloleucel）The label update includes the overall survival (OS) analysis from the landmark Phase III ZUMA-7 study.

TheThe analysis results show，YescarTA vs. Standard of Care (SOC)) Compared, with a statistically significant improvement in OS, Yescarta canAs a second-lineTherapy used to complete first-line treatmentAfterPatients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months.

ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus SOC in adult patients with R/R LBCL who received initial treatment within 12 months of first-line therapy. In this study, 359 patients from 77 centers worldwide were randomly assigned (1:1) to receive a single infusion of Yescarta or previous SOC second-line treatment.Primary EndpointEFS determined by blinded central review.Primary and Secondary EndpointsIncluding objective response rate (ORR) and OS. Other secondary endpoints include patient-reported outcomes (PROs) and safety.

The results of the ZUMA-7 study indicateCompared with SOC, Yescarta reduced the risk of death by 27.4% and relatively improved OS by 38%. The overall median follow-up time was estimated to be 46.7 months. The primary analysis of OS showed a statistically significant improvement in the Yescarta treatment group compared with the standard treatment group, even though more than half of the patients (57%) in the SOC treatment group subsequently received non-protocol cellular therapy. The estimated 39-month OS rate was 55.9% in the Yescarta treatment group and 46% in the SOC treatment group.

Compared with SOC, the number of patients who survived without cancer progression or the need for other cancer treatments after two years of Yescarta treatment increased 2.5 times (40.5% vs. 16.3%), and the median EFS (8.3 months vs. 2.0 months) increased fourfold (hazard ratio 0.398; 95% CI: 0.308-0.514, P<0.0001). The ZUMA-7 study is the largest and longest-running study of its kind. Additionally, participants in the Yescarta treatment group did not receive additional bridging chemotherapy, which might have influenced the study results.

Frank Neumann, MD, Senior Vice President and Global Head of Clinical Development at Kite Pharma, stated"The label update for Yescarta in the United States is an important step in strengthening the confidence of healthcare providers, enabling them to confidently treat eligible patients with Yescarta immediately after the progression or relapse of large B-cell lymphoma. Our ZUMA-7 overall survival analysis demonstrates that Yescarta, as a second-line therapy, is even more effective than standard care in improving patient survival. Combined with our rapid and reliable manufacturing process, we hope to offer patients an opportunity to prolong life.""

Reference: Company's official website