Breyanzi CAR-T trials meet primary endpoints for follicular, mantle cell lymphomas
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Two clinical trials evaluating lisocabtagene maraleucel met their primary endpoints by demonstrating meaningful overall response rates among adults with follicular or mantle cell lymphomas, according to the agent’s manufacturer.
Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) — commonly called liso-cel — is a CD19-directed chimeric antigen receptor T-cell therapy.
The agent is approved in the United States for adults with relapsed or refractory large B-cell lymphoma who received two or more lines of systemic therapy. The agent also is approved for those whose disease is refractory to or relapsed within 12 months of first-line chemoimmunotherapy, as well as those whose disease is refractory to or relapsed after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to age or comorbidities.
The single-arm multicenter phase 2 TRANSCEND FL trial evaluated liso-cel for adults with relapsed or refractory follicular lymphoma. The multicenter phase 1 TRANSCEND NHL 001 trial assessed liso-cel for adults with relapsed or refractory B-cell non-Hodgkin lymphoma, including mantle cell lymphoma.
Both studies achieved their primary endpoints of ORR by “demonstrating statistically significant and clinically meaningful responses” among patients with relapsed or refractory disease, according to a press release from the manufacturer.
Both trials also achieved key secondary endpoints by “demonstrating high rates of complete responses” among study participants, the release added.
Researchers observed no new safety signals in the trials.
“For people living with relapsed or refractory follicular lymphoma or mantle cell lymphoma, there are limited treatment options that provide deep and durable responses, especially for patients with high-risk disease,” Anne Kerber, MD, senior vice president and head of cell therapy development at Bristol Myers Squibb, said in the release “We believe these data further confirm Breyanzi’s best-in-class and best-in-disease profile, and underscore the significant progress we are making in bringing the promise of our differentiated CAR T-cell therapy to more patients.”
Complete results from both studies are still being evaluated and will be presented at a medical meeting, according to the release.
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