Kite, a Gilead Company (GILD), announced the primary overall survival analysis
results of the Phase 3 ZUMA-7 study. The results showed a statistically significant improvement for Yescarta in overall survival versus historical treatment, which was the standard of care in a curative setting for nearly 30 years, for initial treatment of adult patients with relapsed/refractory large B-cell lymphoma within 12 months of completion of first-line therapy.
ZUMA-7 was conducted under a Special Protocol Assessment with the FDA. ZUMA-7 is the first Phase 3 study of any CAR T-cell therapy, with the longest follow-up, which has showed event-free survival, the primary endpoint, that is superior to historical
SOC treatment. Data from the ZUMA-7 trial led to the U.S. approval for initial treatment of R/R LBCL in April 2022 and European Union approval in October 2022.
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