Bristol Myers Squibb said its registrational Phase II QUINTESSENTIAL trial of arlocabtagene autoleucel met its primary and key secondary efficacy endpoints in adults with heavily pretreated relapsed or refractory multiple myeloma.
The open-label, single-arm study evaluated arlocabtagene autoleucel, known as arlo-cel, in patients exposed to four treatment classes, including prior therapies targeting B-cell maturation antigen, or BCMA. Participants had received at least three or four earlier lines of treatment, depending on the endpoint assessment.
The trial met its primary endpoint of overall response rate among quadruple-class-exposed patients who had received four or more prior treatment lines. Overall response was defined as achieving at least a partial response.
The study also met the key secondary endpoint of complete response rate in that four-or-more-prior-line population. It further met overall response and complete response endpoints in quadruple-class-exposed patients who had received three or more prior treatment lines.
Bristol Myers Squibb did not disclose response rates, complete-response rates, durability data, patient numbers, follow-up duration or comparative data. The company said detailed results would be presented at a future medical meeting.
Arlo-cel is an autologous chimeric antigen receptor T-cell therapy targeting GPRC5D, a receptor expressed on plasma cells in multiple myeloma. Its expression is independent of BCMA and remains present after earlier BCMA-directed therapy, according to the company.
Treatment requires a patient’s T cells to be collected from the blood, followed by bridging therapy, manufacturing of the personalized CAR-T product, lymphodepleting chemotherapy, administration of arlo-cel and monitoring for side effects.
The safety profile was consistent with those of other CAR-T therapies and GPRC5D-targeted treatments for multiple myeloma, Bristol Myers Squibb said.
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