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Kite's CAR T-cell Therapy Improves Survival By 60% Over Chemotherapy Plus Stem Cell Transplant

Kite's, a Gilead Company (GILD), Yescarta CAR T-cell therapy improved event-free survival by 60% over chemotherapy plus stem cell transplant in second-line relapsed or refractory large B-cell lymphoma, as per the primary analysis of a randomized phase 3 global, multicenter study ZUMA-7. The interim analysis of overall survival showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future.

The zuma-7 study was initiated in 2017 as the first randomized clinical trial to test the earlier use of a CAR t-cell therapy against standard of care.

The company noted that the study met the primary and key secondary endpoints of event-free survival and objective response rate, demonstrating a highly statistically and clinically significant improvement compared to standard of care.

The company noted that the safety results from the study were consistent with or lower than the known safety profile of Yescarta for the treatment of LBCL in the third-line setting. Six percent of patients experienced cytokine release syndrome (CRS) Grade 3 or higher, with a median onset of three days, and 21% experienced neurological events Grade 3 or higher. No new safety concerns were identified in this second-line setting.

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