FDA Approval Insights: Liso-Cel in Refractory Large B-Cell Lymphoma

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

OncLive On Air^TM 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 Jeremy S. Abramson, MD, director of the Jon and JoAnn Hagler Center for Lymphoma at Massachusetts General Hospital, and associate professor of medicine at Harvard Medical School, to discuss the FDA approval of lisocabtagene maraleucel (liso-cel; Breyanzi) in refractory large B-cell lymphoma.

On February 5, 2021, the FDA approved liso-cel for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment. The approval of the CD19-directed CAR T-cell therapy represents another highly effective option for patients, said Abramson.

The regulatory decision was based on findings from the phase 1 TRANSCEND NHL 001 trial in which liso-cel elicited an objective response rate of 73% and a complete response rate of 53% in patients with heavily pretreated large B-cell lymphoma. Moreover, the median time to first complete response or partial response was 1 month, suggesting patients can obtain rapid responses with liso-cel, added Abramson. Moreover, the median duration of response had not yet been reached at a median follow-up of 12 months.

In our exclusive interview, Abramson discussed the significance of the FDA approval of liso-cel in refractory large B-cell lymphoma and provided insight into the efficacy and safety profiles of the CAR T-cell therapy as reported in the TRANSCEND NHL 001 trial.