BMS Advances Breyanzi in Marginal Zone Lymphoma, Bolstering Portfolio Amid Patent Challenges

Bristol Myers Squibb (BMS) has announced positive results from a mid-stage trial of its CAR T cell therapy Breyanzi in marginal zone lymphoma, potentially expanding the drug's indications and strengthening the company's position as it faces impending patent expirations for key products.

Breyanzi Shows Promise in New Indication

The Phase II TRANSCEND FL trial met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful overall response rate in patients with marginal zone lymphoma. The study also achieved its key secondary endpoint of complete response rate, with Breyanzi exhibiting a durable response profile. Safety findings were consistent with previous studies, with no new concerns identified.

This development marks the fifth cancer type in which Breyanzi has shown strong clinical benefit, positioning it as a versatile treatment option across a broad array of B-cell malignancies. Rosanna Ricafort, head of Late Development Program Leadership, Hematology and Cell Therapy at BMS, stated that detailed findings from TRANSCEND FL will be presented at an upcoming medical meeting.

Strategic Importance Amid Patent Challenges

The potential expansion of Breyanzi's indications comes at a crucial time for BMS, as the company faces significant loss-of-exclusivity challenges in the coming years. Key products set to lose patent protection include:

• Eliquis, an anticoagulant co-developed with Pfizer, which generated $13.3 billion in revenue in 2024 and faces patent expiration in 2026
• Pomalyst, a multiple myeloma drug also losing exclusivity in 2026
• Yervoy, an anti-CTLA-4 antibody used in various cancer treatments, with patents expiring this year

To mitigate the impact of these patent expirations, BMS is focusing on expanding indications for promising assets like Breyanzi. The company has also implemented aggressive cost-cutting measures, including a $1.5 billion savings initiative last year and a recently announced $2 billion realignment program through 2028.

Breyanzi's Growing Portfolio

Breyanzi has been steadily accumulating approvals across various indications:

• In March 2024, it became the first CAR T cell therapy approved for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the relapsed or refractory setting
• Current indications include large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma

While the marginal zone lymphoma market may not be the largest in oncology, the potential addition of this indication could provide valuable revenue support for BMS as it navigates its patent cliff.