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Longer-term data for Yescarta in r/r follicular lymphoma demonstrates substantial survival improvement over current therapies .- Kite/Gilead Sciences

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Published:14th Jun 2021
Kite, a Gilead Company 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 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). 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 II 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<0.001) versus current therapies in the control cohort. while median os and pfs were both not reached in zuma-5, median pfs and os were 12.7 months and 59.8 months, respectively, in the control cohort. in the zuma-5 safety analysis set (n="146)," grade 3 or higher cytokine release syndrome (crs) and neurologic toxicities occurred in 8% and 21% of patients, respectively.></0.001)>

Condition: Follicular + Marginal Zone Lymphoma
Type: drug

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