Research & Development

Kite’s Yescarta CAR T-cell therapy shows statistically significant improvement in overall survival

Kite has announced the primary overall survival (OS) analysis results of a phase 3 study into Yescarta for the treatment of adult patients with relapsed/ refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy. The results showed a statistically significant improvement following treatment with Yescarta compared to the previous standard of care (SOC).
Previously, patients have been treated with platinum-based salvage combination chemoimmunotherapy regimens, then high-dose therapy (HDT) and stem cell transplants for those who responded well to the salvage chemotherapy.
OS was chosen as a clinically important prespecified key secondary endpoint, and has been defined as the length of time from randomisation to death by any cause. The ZUMA-7 trial was part of a Special Protocol Assessment (SPA) with the FDA, meaning the agency agreed the trial design, clinical endpoints and statistical analysis prior to the beginning of the trial. This was also agreed upon by other health authorities.
The Zuma-7 trial has been called a ‘landmark trial’ as it is the first and largest phase 3 trial 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,’ according to Kite’s press release.