BMS GPRC5D-directed CAR-T therapy meets endpoints in phase 2 trial

Bristol Myers Squibb announced positive phase 2 results from the registrational QUINTESSENTIAL trial of its G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CAR-T cell therapy, arlocabtagene autoleucel, in adult patients with quadruple-class exposed relapsed and refractory multiple myeloma.

Results show the study met its primary endpoint, with arlo-cel demonstrating a statistically significant and clinically meaningful overall response rate (ORR) in patients with quadruple-class exposed RRMM who had received four or more prior lines of therapy. Quadruple-class exposed consists of those who had been treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy and a BCMA-targeted therapy.

The study also met the key secondary endpoint of complete response rate (CRR) in patients with RRMM who had been quadruple-class exposed after four or more prior lines of therapy, and the key secondary endpoints of ORR and CRR after three or more prior lines of therapy. According to BMS, the safety profile of arlo-cel was consistent with that of other CAR-T cell therapies and other GPRC5D-targeting therapies in multiple myeloma.

The company plans to present results from the QUINTESSENTIAL trial at an upcoming medical meeting.

GPRC5D is a receptor expressed on plasma cells in multiple myeloma, with limited expression on healthy cells, and is a validated therapeutic target in multiple myeloma. Arlo-cel is designed to recognize and bind to GPRC5D in order to target and eliminate GPRC5D-expressing myeloma cells.