Kite Says Tecartus Shows Prolonged OS In Adults With Refractory B-cell Acute Lymphoblastic Leukemia

(RTTNews) - Kite, a Gilead Sciences, Inc. Company (GILD), announced Monday updated, four-year overall survival (OS) data from the pivotal ZUMA-3 study evaluating the CAR T-cell therapy Tecartus (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

The findings showed a median Overall Survival (OS) of 25.6 months and a four-year OS rate of 40% in all treated patients with a safety profile consistent with that observed in the three-year analysis.

ZUMA-3 is an ongoing international multicenter (US, Canada, Europe), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation.

The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment.

The duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and alloSCT rate were assessed as secondary endpoints.