Kite announces findings from two new analyses of ZUMA-7 trial of Yescarta

Kite, a Gilead company, announced findings from two new analyses of the landmark ZUMA-7 trial of Yescarta, the largest and longest follow-up of a CAR T-cell therapy versus standard of care in patients with relapsed or refractory large B-cell lymphoma. These results include an analysis of outcomes for patients who received subsequent treatment for their lymphoma following second-line Yescarta therapy or SOC therapy, as well as an exploratory analysis of the association between metabolic tumor volume and clinical outcomes. Data from the pivotal ZUMA-7 trial supported the U.S. Food and Drug Administration’s expanded approval of Yescarta in April 2022 as initial treatment in adults with r/r LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and led to a similar approval by the European Medicines Agency in October 2022. In an analysis of patients from the ZUMA-7 trial who required subsequent therapy following second-line treatment, 47% of patients randomized to receive Yescarta in the second-line required subsequent therapy compared to 71% patients randomized to 2L standard of care. For patients who received third-line chemotherapy following treatment with Yescarta, overall median progression-free survival was 1.7 months and median overall survival was 8.1 months since 3L treatment initiation, with an objective response rate of 25%. Among Yescarta patients who received 3L cellular immunotherapy, median PFS was 3.5 months, and six patients went on to receive subsequent stem cell transplant, with all six alive at data cutoff. Of the patients who received retreatment with CAR T-cell therapy in 3L, but did not progress on to stem cell transplant, one had fatal disease progression at 8.7 months following retreatment, and one had a complete response and was alive at data cutoff (8.4 months following retreatment). Thirty-four of these patients received 3L chemotherapy following initial response to 2L Yescarta. Among those patients, overall median PFS was 1.7 months and median OS was 8.1 months, with an ORR of 32%. Among patients randomized to SOC who received 3L cellular immunotherapy, median PFS was 6.3 months and median OS was 16.3 months. In an analysis from ZUMA-7 of the association of metabolic tumor volume and clinical outcomes, event-free survival was superior for Yescarta compared to SOC for patients with high and low MTV. EFS trended shorter in Yescarta patients with high MTV and EFS was shorter in SOC patients with high MTV. Similarly, PFS with Yescarta was superior to SOC for both low and high MTV. In the Yescarta arm, median MTV was higher in patients who experienced Grade greater than or equal to3 neurologic events or Grade greater than or equal to3 cytokine release syndrome compared with patients who experienced Grade 1-2 or no neurologic events or Grade 1-2 or no CRS, respectively.