Bristol Myers Squibb (NYSE: BMY) today announced positive Phase 2 results from the registrational QUINTESSENTIAL trial of arlocabtagene autoleucel (arlo-cel; BMS-986393) in adult patients with quadruple-class exposed relapsed and refractory multiple myeloma (RRMM). Arlo-cel is a potential first-in-class autologous G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CAR T cell therapy. As a CAR T cell therapy designed to be administered as a single infusion, arlo-cel potentially represents a differentiated approach for patients with heavily pretreated 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 (IMiD), a proteasome inhibitor (PI), 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.
The safety profile of arlo-cel was consistent with that of other CAR T cell therapies and other GPRC5D-targeting therapies in multiple myeloma.
BMY shares lost $1.87, or 2.8%, to begin Tuesday trading at $64.95.
