Brexucabtagene Autoleucel Demonstrates High Response Rate with Relapsed, Refractory B-cell Acute Lymphoblastic Leukemia

The findings led to the FDA accepting the supplemental Biologics License Application and Priority Review designation for treatment, according to a Gilead press release.

Results from the primary analysis of ZUMA-3 study evaluating the chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel (Tecartus, Gilead) showed a high response rate in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The findings led to the FDA accepting the supplemental Biologics License Application and Priority Review designation for treatment, according to a Gilead press release.

“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, in a press release. “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.”

Brexucabtagene autoleucel uses the XLP manufacturing process that includes T cell enrichment, which is a crucial step in specific B-cell malignancies in which circulating lymphoblasts are a common feature.

The phase 2 trial analyzed 71 patients with relapsed or refractory disease, and out of the 55 treated patients enrolled, 47% had received 3 or more prior therapies. At the 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. Further, 97% of the responders had deep molecular remission, with undetectable minimal residual disease and median overall survival (OS) among all responders not yet reached, according to the study authors.

Of 25 patients previously treated with blinatinumomab, the CR/CRi rate was 60%, whereas the median duration of response, relapse-free survival, and OS among all patients who were treated were 12.8 months, 11.6 months, and 18.2 months, respectively.

“The data presented at ASCO [June 4] validate the response rates seen in the phase 1 portion of the ZUMA-3 study and the transformative potential of Tecartus in adult patients with ALL,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development, in the press release. “We have already seen the impact of Tecartus for patients with relapsed or refractory mantle cell lymphoma, and these new data are a significant next step in our continued commitment in developing our therapies for patients with leukemias and lymphomas.”

REFERENCE

Kite's Tecartus® Demonstrates High Response Rate in Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Earning Priority Review Designation. Gilead. Published June 4, 2021. Accessed June 16, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/6/kites-tecartus-demonstrates-high-response-rate-in-adults-with-relapsed-or-refractory-bcell-acute-lymphoblastic-leukemia-earning-priority-review-des