With positive mid-stage results in marginal zone lymphoma, Bristol Myers Squibb could soon add a new indication for the CAR T cell therapy—potentially helping to offset loss-of-exclusivity headwinds.
Bristol Myers Squibb could soon be adding another indication to Breyanzi’s label, with a topline readout from a mid-stage study on Monday pointing to the CAR T cell therapy’s potential in marginal zone lymphoma.
The pharma did not provide specific data from the Phase II TRANSCEND FL trial in its press announcement, revealing only that Breyanzi met its primary efficacy endpoint, eliciting a “statistically significant and clinically meaningful” overall response rate. Breyanzi also met the trial’s key secondary endpoint of complete response rate, while also demonstrating a durable response profile.
As for safety, TRANSCEND FL found Breyanzi’s side effects to be consistent with what had been established in prior studies, with no new signals of concern.
With Monday’s readout, Breyanzi has now shown strong clinically meaningful benefit in five cancer types, BMS wrote in its news release, claiming that this represents “the broadest array of B-cell malignancies of any CD19-direct CAR T cell therapy” and further emphasizes the drug’s “best-in-class and best-in-disease profile.”
BMS will present detailed findings from TRANSCEND FL at an upcoming medical meeting, according to Rosanna Ricafort, head of Late Development Program Leadership, Hematology and Cell Therapy.
Breyanzi is one of seven CAR T therapies currently approved, alongside Abecma, also from BMS, and Johnson & Johnson and Legend Biotech’s Carvykti.
In March 2024, Breyanzi became the first CAR T cell therapy for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the relapsed or refractory setting.
Breyanzi is also indicated for large B cell lymphoma, follicular lymphoma and mantle cell lymphoma.
Though not exactly the biggest cancer market, an approval for Breyanzi in marginal zone lymphoma could still be valuable for BMS as it faces strong loss-of-exclusivity headwinds in the coming years. Its Pfizer-partnered anticoagulant Eliquis, which brought in $13.3 billion in 2024, is set to lose key patent protections in 2026, as will its multiple myeloma drug pomalyst. Yervoy, an anti-CTLA-4 antibody indicated for many types of cancer, faces patent expirations this year.
Unfortunately for BMS, its late-pipeline does not appear strong enough to offset the loss of revenue from these headwinds, according to a January 2025 report from William Blair, which noted, however, that standout assets—Breyanzi, alongside the PD-1 blocker Opdivo, schizophrenia drug Cobenfy and heart drug Camzyos—will help soften the blow somewhat.
To cushion its bottom line, BMS has set in motion aggressive cost-cutting programs, including a $1.5-billion savings push last year and the recently announced $2 billion realignment program through 2028.
