NEW YORK – Bristol Myers Squibb on Monday said it will share with health authorities promising data on the activity of its CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) in patients with follicular lymphoma and B-cell non-Hodgkin lymphoma.
The company said two Breyanzi trials, the Phase II TRANSCEND FL and Phase I TRANSCEND NHL 001 studies, met their primary endpoints by showing that the CAR T-cell therapy positively impacted patients' overall response rates. Follicular lymphoma and mantle cell lymphoma patients on Breyanzi in these trials also had high complete response rates, which was a secondary endpoint in both trials.
TRANSCEND FL is a single-arm Phase II trial evaluating Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma including follicular lymphoma and marginal zone lymphoma. TRANSCEND NHL 001 is a pivotal Phase I trial of Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma grade 3B, and mantle cell lymphoma.
In addition to discussing the data with health authorities, BMS said it will present results from the studies at an upcoming medical meeting.
Breyanzi, a CD19-directed CAR T-cell therapy, is currently approved in the US as a second- and third-line treatment for large B-cell lymphomas. Earlier this year, BMS also reported positive data from a Phase I/II trial of Breyanzi in chronic lymphocytic leukemia or small lymphocytic lymphoma.
In follicular lymphoma, Breyanzi would compete with Gilead Sciences' Yescarta (axicabtagene ciloleucel), which was approved in this setting in the US in 2021, and with Novartis' Kymriah (tisagenlecleucel), which was approved last year. Gilead's Tecartus (brexucabtagene autoleucel) is approved in the US and Europe as a treatment for mantle cell lymphoma.