Bristol Myers Squibb's Breyanzi Gains Ground in CAR-T Therapy Race with Positive Trial Results in Marginal Zone Lymphoma

Bristol Myers Squibb (BMS) has announced positive results from the marginal zone lymphoma (MZL) cohort of its phase 2 TRANSCEND FL trial, potentially positioning its CD19-directed CAR-T therapy Breyanzi for a new indication. This development marks another step in BMS's efforts to close the gap with Gilead Sciences in the competitive CAR-T therapy market.

Breyanzi Demonstrates Efficacy in Multiple Blood Cancers

The latest trial results show that Breyanzi met its primary endpoint of overall response rate and the key secondary endpoint of complete response rate in patients with MZL. This success adds to Breyanzi's growing list of positive readouts across various blood cancers, making it the CD19-directed CAR-T therapy with demonstrated clinical benefit in the most cancer types.

Rosanna Ricafort, BMS's head of hematology and cell therapy late development, emphasized the significance of this development: "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."

Expanding Indications and Market Competition

Breyanzi has now shown clinical benefit in five cancer types, including:

1. Large B-cell lymphoma
2. Follicular lymphoma (FL)
3. Chronic lymphocytic leukemia (CLL)
4. Small lymphocytic lymphoma (SLL)
5. Mantle cell lymphoma

The therapy received accelerated FDA approval for third-line FL in 2024, based on data from the follicular lymphoma cohort of the TRANSCEND FL study. Additionally, in March 2024, Breyanzi became the first CD19 CAR-T therapy to gain approval for CLL/SLL.

This expansion of indications puts BMS in a strong position to compete with Gilead Sciences, which currently leads the market with its CD19 CAR-T products, Yescarta and Tecartus. Gilead's therapies are approved for four cancer types, including an acute lymphoblastic leukemia indication that Breyanzi does not yet have.

Market Performance and Future Outlook

Breyanzi's market performance has been promising, with 2024 sales reaching $747 million, including a notable $263 million in the fourth quarter – a 160% increase year over year. This growth comes at a time when Gilead's Yescarta has experienced a slowdown, with a 1% sales decline to $387 million in the third quarter of 2024.

As BMS continues to expand Breyanzi's indications and improve its market position, the CAR-T therapy landscape is becoming increasingly competitive. With both companies investing heavily in research and development, the race to dominate the CAR-T market is likely to intensify in the coming years.