With another trial win, Bristol Myers Squibb is touting Breyanzi as the CD19-directed CAR-T therapy with positive readouts in the most cancer types.
The latest readout positions Breyanzi for a potential foray into marginal zone lymphoma (MZL), for which none of the existing CAR-T therapies are approved by the FDA.
Monday, BMS said the MZL cohort of the phase 2 TRANSCEND FL trial met its primary endpoint of overall response rate and the key secondary endpoint of complete response rate.
Last year, tumor response data from the follicular lymphoma (FL) cohort of the study, which enrolled patients with previously treated indolent non-Hodgkin lymphoma, enabled Breyanzi to secure an accelerated FDA approval in third-line FL.
“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,” Rosanna Ricafort, BMS’ head of hematology and cell therapy late development, said in a statement Monday.
MZL marks the fifth cancer type for which Breyanzi has demonstrated a clinically meaningful benefit, according to BMS. With an FDA accelerated approval in March 2024, Breyanzi became the first CD19 CAR-T to break into chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Besides FL and CLL/SLL, Breyanzi is also allowed to treat large B-cell lymphoma and mantle cell lymphoma.
Gilead Sciences boasts four approved cancer types between its two CD19 CAR-T products, Yescarta and Tecartus, one being an acute lymphoblastic leukemia indication that Breyanzi doesn’t have.
Gilead ran a trial similar to BMS’ TRANSCEND FL. Dubbed ZUMA-5, the trial also enrolled both FL and MZL patients. But the size of the MZL cohort, 31 patients in a recent update, appeared to be too small to support any regulatory action.
Among all 159 patients enrolled in ZUMA-5, Yescarta induced an overall response rate of 90%, including a 75% rate of complete responses, according to a five-year update presented at the American Society of Hematology annual meeting in December.
In the MZL cohort, the response numbers were 77% and 65%, respectively. The median duration of response was still not reached in the MZL patients.
As a latecomer in the CD19 game, Breyanzi is trying to catch up with Yescarta in terms of market share. For 2024, Breyanzi brought in $747 million in sales, including $263 million from the fourth quarter, which marked a 160% jump year over year.
Gilead will report its full-year earnings performance Tuesday. Yescarta has recently hit a growth bottleneck as Gilead tries to expand the difficult-to-make cell therapy to more treatment centers. Citing in- and out-of-class competition in the U.S., Gilead reported a 1% sales decline for Yescarta in the third quarter to $387 million.