BMS touts Breyanzi efficacy across multiple cancer types, sharing marginal zone lymphoma data

Bristol Myers Squibb announced that a phase 2 trial evaluating its CD19-directed CAR-T cell therapy, Breyanzi, in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort.

According to BMS, with this data, Breyanzi demonstrates efficacy and manageable safety in a fifth cancer type — the most of any CD19-directed CAR-T cell therapy.

In the TRANSCEND FL trial, Breyanzi demonstrated a statistically significant and clinically meaningful overall response rate in the MZL cohort and also met the key secondary endpoint of complete response rate. The treatment continued to demonstrate durable responses and a consistent safety profile with no new safety signals observed.

MZL is the second most common, slow-growing form of non-Hodgkin lymphoma, accounting for about 7% of all NHL cases.

“Marginal zone lymphoma is a slow-growing cancer that, for many, has a favorable prognosis. But for those patients who relapse or become refractory, the disease can be quite aggressive, and there is a need for new effective and tolerable treatment options to address this unmet critical need,” said Rosanna Ricafort, vice president, head of Late Development Program Leadership, Hematology and Cell Therapy at BMS.

First approved in the U.S. in 2021, Breyanzi is now FDA approved for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy; relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy; relapsed or refractory follicular lymphoma in adult patients who have received two or more prior lines of systemic therapy; and relapsed or refractory mantle cell lymphoma in patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.