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Kite's Tecartus® Demonstrates High Response Rate in Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Earning Priority Review Designation
-- 71% of Adult Patients in Phase 2 ZUMA-3 Study Achieved a Complete Response Following a Single Infusion of Tecartus -- -- Findings Support Recent
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- 71% of Adult Patients in Phase 2 ZUMA-3 Study Achieved a Complete Response Following a Single Infusion of Tecartus --\n\n-- Findings Support Recent Supplemental Biologics License Application (sBLA) for Tecartus Accepted for Priority Review by the U.S. Food & Drug Administration (FDA) --\n\n-- If Approved, Tecartus Would Be the First and Only CAR T-Cell Therapy Approved for Adult Patients (18 Years and Older) with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia --\n\n SANTA MONICA, Calif.--(BUSINESS WIRE)--\nKite, a Gilead Company (Nasdaq: GILD), announced today results from the primary analysis of ZUMA-3, a global, multicenter, single-arm, open-label Phase 1/2 study evaluating its chimeric antigen receptor (CAR) T-cell therapy Tecartus® (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The data were simultaneously published in The Lancet and presented during an oral session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4 – 8 (Abstract #7002).\n\n“Outcomes in adults with acute lymphoblastic leukemia are poor relative to what is observed in children, with less than half of people over 20 years of age expected to survive the illness. It is on this background that CAR T-cell therapy with brexucabtagene autoleucel was tested in adults with relapsed B-ALL in ZUMA-3,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. “In this international, multicenter study, we observed a response rate of 71%. Importantly, the majority of these responses were associated with undetectable minimal residual disease.”\n\nIn the pivotal Phase 2 portion of the trial, 71 patients with relapsed or refractory disease were enrolled. Among treated patients (n=55), 47% had received three or more prior therapies. At a median follow-up of 16.4 months, 71% of treated patients achieved a complete response (CR) or CR with incomplete hematological recovery (CRi), with 31% in ongoing response at data cut-off. 97% of those responders had deep molecular remission, with undetectable minimal residual disease (MRD), and median overall survival (OS) among all responders was not reached. Among 25 patients with prior blinatumomab treatment, the CR/CRi rate was 60%. Among all treated patie...