FDA Approval Insights: Brexucabtagene Autoleucel in Relapsed/Refractory B-ALL

Welcome to OncLive On Air^®! I’m your host today, Caroline Seymour.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Bijal Shah, MD, MS, an associate member in the Department of Malignant Hematology at Moffitt Cancer Center, to discuss the FDA approval of brexucabtagene autoleucel (Tecartus) for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).

On October 1, 2021, the FDA approved brexucabtagene autoleucel for patients with relapsed/refractory B-cell precursor ALL. The approval was based on findings from the phase 1/2 ZUMA-3 trial (NCT02614066), which showed that the complete response/complete response with incomplete blood count recovery (CR/CRi) rate was 70.9%, which included a CR rate of 56.4%. As of the data cutoff, 31% of patients who achieved a CR/CRi were in ongoing remission without subsequent allogeneic stem cell transplant.

The median duration of response with censoring at subsequent allogeneic stem cell transplant, relapse-free survival, and overall survival (OS) was 12.8 months (95% CI, 8.7-not estimable [NE]), 11.6 months (95% CI, 2.7-15.5), and 18.2 months (95% CI, 15.9-NE), respectively. The median OS was not reached in patients who achieved CR/CRi.

These data are unprecedented in such a heavily pretreated population of patients with ALL, said Shah. The magnitude of benefit in OS with brexucabtagene autoleucel in this patient population has never been achieved in prior trials in this setting, marking a significant advance for the field, added Shah.

In our exclusive interview, Shah discussed the FDA approval of brexucabtagene autoleucel in relapsed/refractory B-ALL, key findings from the pivotal ZUMA-3 trial, and next steps with CAR T-cell therapy in the field.

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