Bristol Myers Squibb has announced that its phase II QUINTESSENTIAL trial of arlocabtagene autoleucel (arlo-cel; BMS-986393) met its primary endpoint in adults with relapsed and refractory multiple myeloma who had already received four classes of therapy.
Arlo-cel is designed to target GPRC5D, distinguishing it from most approved CAR-T therapies that focus on BCMA, and has shown activity even in patients previously treated with BCMA-directed therapies.
Arlocabtagene autoleucel, or arlo-cel, is the main therapy studied in this trial. According to a company-event tracker on MarketBeat, the trial met both its primary endpoint of overall response rate and a key secondary endpoint of complete response rate in this heavily pretreated group.
Detailed results have not yet been released, but the company confirmed that the main goal was reached. Independent reports described the results as "statistically significant and clinically meaningful" for overall response rate, though exact numbers are not yet available. More details are expected at a future medical meeting.
The QUINTESSENTIAL program is not limited to phase II: a phase III trial, QUINTESSENTIAL-2, is ongoing in adults with relapsed/refractory multiple myeloma after 1–3 prior lines of therapy, reflecting continued clinical development of arlo-cel beyond the initial cohort.
The Siteman Cancer Center clinical trial listing notes that QUINTESSENTIAL is an open-label, multicenter phase II study looking at both the effectiveness and safety of arlo-cel in adults with relapsed or refractory multiple myeloma. Bristol Myers Squibb plans to present full trial data at an upcoming medical congress, which should provide more information on how different patient groups responded and how long the benefits lasted.
