Gilead CAR T-cell Therapy Improved Overall Survival In Pretreated Lymphoma
- Kite, a Gilead Science Inc company, announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study.
- The results showed a statistically significant improvement for Yescarta in OS versus historical treatment, which was the standard of care (SOC) in a curative setting for nearly 30 years, for initial treatment of adult patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy.
- Historical SOC is a multi-step process involving a platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy (HDT) and a stem cell transplant (ASCT) in those who respond to salvage chemotherapy.
- ZUMA-7 was conducted under a Special Protocol Assessment (SPA) with the FDA, whereby the trial design, clinical endpoints, and statistical analysis were agreed upon in advance with the Agency. Other health authorities also agreed with this pre-specified analysis.
- ZUMA-7 is considered a landmark trial as the first and largest Phase 3 study of any CAR T-cell therapy, with the longest follow-up, which has demonstrated event-free survival (EFS), the primary endpoint, that is superior to historical SOC treatment.
- Data from the ZUMA-7 pivotal trial led to the U.S. approval for the initial treatment of R/R LBCL in April 2022 and European Union approval in October 2022.
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