Brexucabtagene Autoleucel in relapsed / refractory ALL-B
welcome to OncLive On Air®! I am your host today, Caroline Seymour.
OncLive On Air® is a podcast of OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In digital and printed format, OncLive® covers all aspects of oncology practice, from new technologies and therapeutic advances to important regulatory decisions.
In today’s episode, we had the pleasure of speaking with Bijal Shah, MD, MS, associate member of the Department of Malignant Hematology at Moffitt Cancer Center, to discuss the FDA approval of brexucabtagene autoleucel. (Tecartus) for patients with relapsed / refractory B-acute lymphoblastic cell leukemia (ALL-B).
On October 1, 2021, the FDA approved brexucabtagene autoleucel for patients with relapsed / refractory B cell precursor ALL. The approval was based on the results of the phase 1/2 ZUMA-3 trial (NCT02614066), which showed that the rate of complete response / complete response with incomplete recovery of blood count (CR / RCi) was 70.9%, which included a CR rate of 56.4%. At the data cut-off date, 31% of patients who achieved CR / RCi were in continuous remission without subsequent allogeneic stem cell transplantation.
The median censored response time to subsequent allogeneic stem cell transplantation, 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. Median OS was not achieved in patients who achieved CR / RCi.
This data is unprecedented in such a heavily pre-treated population of ALL patients, Shah said. The magnitude of the benefit of OS with brexucabtagene autoleucel in this patient population has never been achieved in previous trials in this setting, marking a significant breakthrough for the field, added Shah.
In our exclusive interview, Shah discussed the FDA approval of brexucabtagene autoleucel in relapsed / refractory ALL-B, key findings from the pivotal ZUMA-3 trial, and next steps for CAR T-cell therapy. in the field.
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