Bristol Myers Squibb (BMS) has reported that the multi-centre Phase II TRANSCEND FL trial assessing its cluster of differentiation 19 (CD19)-directed CAR T cell therapy, Breyanzi, met its primary endpoint in the marginal zone lymphoma (MZL) arm of adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL).
Findings demonstrated a “statistically significant” overall response rate (ORR), which is the primary outcome measure of this open-label, single-arm trial.
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The trial aimed to demonstrate the therapy’s safety and efficacy in this particular patient group.
The key secondary endpoint of complete response rate (CRR) was also met, with the therapy showing ‘durable’ responses along with a ‘consistent’ safety profile as per the topline analysis.
Bristol Myers Squibb haematology and cell therapy late development program leadership head and vice-president Rosanna Ricafort said: “Marginal zone lymphoma is a slow-growing cancer that, for many, has a favourable 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.
“We are pleased that the TRANSCEND FL study supports the potential of Breyanzi in marginal zone lymphoma and look forward to presenting detailed results from the study at an upcoming medical meeting.”
Breyanzi is stated to leverage the T cells of an individual, which are re-engineered to target CD19-expressing cells and infused back into the individual as a one-time treatment. This therapy includes a 4-1BB costimulatory domain to “enhance” the persistence and expansion of the CAR T cells, stated the company.
Breyanzi is currently approved in the US for several forms of B-cell lymphoma.
BMS continues to expand its clinical development programme for the therapy, investigating its use in other types of lymphoma.
These developments follow the company’s announcement in June 2024 regarding the Phase III CheckMate -9DW trial, which found that Opdivo plus Yervoy improved overall survival rates in subjects with unresectable hepatocellular carcinoma as a first-line treatment.
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