Bristol Myers Squibb Reports Positive Results for Breyanzi in Relapsed/Refractory Marginal Zone Lymphoma

Bristol Myers Squibb has reported significant progress in the Phase 2 TRANSCEND FL trial, which assessed Breyanzi® (lisocabtagene maraleucel) for patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, particularly in the marginal zone lymphoma (MZL) group. The trial results were promising, revealing a statistically significant, clinically meaningful overall response rate (ORR) and meeting the key secondary endpoint of complete response rate (CRR).

Breyanzi's performance in this trial signifies its potential as a treatment for multiple B-cell malignancies, underscoring its versatility as a CD19-directed CAR T cell therapy. The therapy demonstrated durable responses without new safety concerns, reinforcing its status as a top-tier treatment option for these conditions.

Marginal zone lymphoma, a typically slow-progressing type of non-Hodgkin lymphoma, often has a favorable initial prognosis. However, for patients who experience relapse or become refractory, the disease can become more aggressive, necessitating new and effective treatment options. Rosanna Ricafort, a vice president at Bristol Myers Squibb, highlighted the need for improved therapies for these patients and noted the positive findings from the TRANSCEND FL study as a step forward in addressing this need.

The TRANSCEND FL study is an open-label, global, multicenter Phase 2 trial designed to evaluate the efficacy and safety of Breyanzi in patients with specific types of indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and MZL. The primary focus of the study was on the overall response rate, with secondary measures assessing complete response rate, duration of response, and progression-free survival.

Marginal zone lymphoma accounts for approximately 7% of all cases of non-Hodgkin lymphoma, with a median diagnosis age of 67. This type of lymphoma occurs when white blood cells form clusters in lymph nodes or organs, and it manifests in three main forms: extranodal, nodal, and splenic. While initial treatments often yield extended remissions, relapses are common, and some cases transform into more aggressive forms of lymphoma such as diffuse large-B-cell lymphoma.

Breyanzi, which is a CD19-directed CAR T cell therapy, involves using a patient’s own T cells, modified to target cancer cells, and is administered as a one-time infusion. It’s approved in the U.S. for treating relapsed or refractory large B-cell lymphoma (LBCL) after previous therapies and is also used for relapsed or refractory chronic lymphocytic leukemia, follicular lymphoma, and mantle cell lymphoma. Outside the U.S., it is approved in regions such as Japan and Europe for various lymphoma treatments.

The development of Breyanzi is part of Bristol Myers Squibb’s broader strategy to harness cell therapy in the fight against cancer. With two distinct CAR T cell therapies already available in major global markets, the company aims to unlock the full potential of this innovative technology. This ambition is supported by a promising pipeline, comprehensive data, skilled personnel, and strong manufacturing capabilities, all driving towards a revolution in cancer treatment.