Arlocabtagene autoleucel met the primary endpoint of overall response rate (ORR) and all key secondary endpoints in the registrational QUINTESSENTIAL Phase II trial, Bristol Myers Squibb (NYSE: BMY) reported on September 8, 2026. The result positions the GPRC5D-directed CAR T cell therapy for a BLA submission targeting one of the most treatment-resistant populations in multiple myeloma: patients who have already progressed through an immunomodulatory drug, a proteasome inhibitor, an anti-CD38 antibody, and a BCMA-directed therapy.
The trial enrolled adults with quadruple-class exposed relapsed or refractory multiple myeloma (RRMM) who had received at least four prior lines of therapy. BMS described the ORR improvement as statistically significant and clinically meaningful; the complete response rate (CRR) secondary endpoint was also met, as were ORR and CRR endpoints in a broader cohort with three or more prior lines. No numerical data were disclosed — full results are expected at an upcoming medical conference. The safety profile was described as consistent with other CAR T and GPRC5D-targeting therapies.
Arlo-cel, as it is also known, targets GPRC5D, a receptor expressed on malignant plasma cells whose expression is independent of BCMA and is maintained after prior BCMA-directed therapy. By directing engineered autologous T cells against a non-BCMA antigen, the therapy is designed to retain activity in patients where BCMA-targeted agents have already failed. Phase I data presented at ASH 2024 showed an ORR of 87% at a median follow-up of 16.1 months, with median progression-free survival of 18.3 months and median overall survival not reached.