Bristol Myers Squibb has reported primary analysis results from the TRANSCEND open-label, multicentre clinical trials of Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (R/R MCL).
Breyanzi has been evaluated in patients with FL in the single-arm, global Phase II TRANSCEND FL study and in patients with MCL in the Phase I TRANSCEND NHL 001 study.
The primary outcome measure for both the studies includes overall response rate with an addition of treatment-related adverse events, and dose-limiting toxicities in TRANSCEND NHL 001 study.
Complete response rate, duration of response, and progression-free survival are the secondary outcome measures for the trials.
Adults with non-Hodgkin lymphoma including FL received Breyanzi at a target dose of 100 x 106 CAR-positive viable T cells in the second-line and third-line plus setting of the TRANSCEND FL study.
In this trial, 94% of patients with FL treated with Breyanzi achieved a complete response while 81.9% of responders are in ongoing response at 12 months.
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By GlobalDataThe R/R MCL cohort’s adults previously treated with two or more prior lines of therapy, including a BTK inhibitor, received Breyanzi at dose levels of either 50 x 106 or 100 x 106 CAR-positive viable T cells.
It showed that 86.5% of patients with MCL achieved a response with 74.3% achieving a complete response.
A manageable safety profile of Breyanzi with no new safety signals was observed in both studies along with low rates of severe cytokine release syndrome and neurologic events.
Bristol Myers Squibb cell therapy development head and senior vice-president Anne Kerber said: “With Breyanzi, we’re dedicated to delivering a CAR T cell therapy with a differentiated profile to transform outcomes for some of the most difficult-to-treat lymphomas.”
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