Kite, a Gilead Company (Nasdaq: GILD), today announced follow-up results from the pivotal ZUMA-5 trial of Yescarta (axicabtagene ciloleucel) - the first and only CAR T-cell therapy approved in patients with relapsed or refractory indolent follicular lymphoma (FL).
At a minimum follow-up of 18 months, 94% of patients had achieved a response, and secondary endpoints of median progression-free survival (PFS) and overall survival (OS) were not yet reached. In a weighted analysis comparing ZUMA-5 patients with a minimum of 18 months follow-up with those observed in SCHOLAR-5, an external control cohort, Yescarta demonstrated superior OS and PFS over currently available treatments. These data were presented today as a part of a late-breaking session at the 26th Annual Meeting of the European Hematology Association (EHA2021) taking place virtually this year from June 9-17 (Abstract #LB1904).
'Follicular lymphoma is one of the most common non-Hodgkin lymphomas, and patients can experience frequent relapses, which quickly leaves us short of treatment options,' said Professor John Gribben, Professor of Medical Oncology at the Cancer Research UK Barts Centre, London, UK and study author. 'We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.'
The propensity score analysis compared follow-up data (median follow-up of 23.3 months; in at least 80 patients with FL) from the pivotal Phase 2 ZUMA-5 study (n=86) to a weighted sample from the SCHOLAR-5 external control cohort of current therapies (n=85), balanced for patient characteristics through propensity scoring. Ninety-four percent of patients in the ZUMA-5 cohort achieved a response compared to 50% of patients in the control cohort (median follow-up of 26.2 months), with an odds ratio of 16.2 (95% confidence interval [CI]: 5.6-46.9). Yescarta demonstrated a 58% reduction in the risk of death (HR: 0.42; 95% CI: 0.21-0.83, p=0.01) and 70% reduction in the risk of disease progression, relapse or death (HR: 0.30; 95% CI: 0.18-0.49, p
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