Pharmaceutical giant Bristol Myers Squibb (BMS) has achieved another significant milestone with its CD19-directed CAR-T therapy, Breyanzi. The latest trial results indicate promising outcomes for treating marginal zone lymphoma (MZL), a condition not yet addressed by any FDA-approved CAR-T therapies. This success builds on Breyanzi's previous achievements in follicular lymphoma and chronic lymphocytic leukemia. The phase 2 TRANSCEND FL trial demonstrated positive overall and complete response rates, positioning Breyanzi as a potential game-changer in MZL treatment. With growing competition in the CAR-T therapy market, these advancements highlight Breyanzi's expanding therapeutic scope and market presence.

Detailed Insights into Breyanzi's Latest Breakthrough

In a remarkable development, BMS announced on a recent Monday that the MZL cohort of the phase 2 TRANSCEND FL trial met its primary endpoint of overall response rate and key secondary endpoint of complete response rate. This pivotal moment underscores Breyanzi's potential to address an unmet need in MZL, a slow-growing cancer that can become aggressive in relapsed or refractory cases. Dr. Rosanna Ricafort, BMS' head of hematology and cell therapy late development, emphasized the importance of effective and tolerable treatment options for these patients.

Breyanzi has now shown clinically meaningful benefits across five cancer types, including follicular lymphoma, chronic lymphocytic leukemia, large B-cell lymphoma, mantle cell lymphoma, and now MZL. Notably, Breyanzi secured an accelerated FDA approval in March 2024 for CLL, marking it as the first CD19 CAR-T therapy to do so. In contrast, Gilead Sciences' Yescarta and Tecartus have approvals for four cancer types but lack an indication for acute lymphoblastic leukemia.

Gilead conducted a similar trial, ZUMA-5, which enrolled both follicular lymphoma and MZL patients. However, the smaller size of the MZL cohort limited its regulatory impact. Among all 159 patients in ZUMA-5, Yescarta achieved an impressive overall response rate of 90%, with 75% achieving complete responses. For the MZL subgroup, the response rates were 77% and 65%, respectively, with a median duration of response not yet reached.

Breyanzi's market performance is also noteworthy. Despite being a late entrant in the CD19 CAR-T space, Breyanzi reported $747 million in sales for 2024, including a robust fourth-quarter revenue of $263 million, representing a 160% year-over-year increase. Meanwhile, Gilead faces challenges with Yescarta, reporting a slight decline in third-quarter sales due to competition and expansion difficulties.

From a journalist's perspective, Breyanzi's continued success highlights the rapid evolution and competitive nature of the CAR-T therapy market. The ability to offer new treatment options for previously underserved patient populations, such as those with MZL, underscores the importance of innovation in oncology. As Breyanzi expands its therapeutic reach, it not only addresses critical unmet needs but also sets a benchmark for future advancements in personalized medicine. This progress invites optimism about the potential for more effective and targeted cancer treatments in the years to come.