WS Investor
09 Sep 2026, 15:59
Bristol Myers Squibb’s Arlo-Cel Meets Primary Endpoint in Phase 2 Multiple Myeloma Trial
Bristol Myers Squibb (NYSE: BMY) announced positive topline results from the registrational Phase 2 QUINTESSENTIAL trial evaluating arlocabtagene autoleucel, or arlo-cel, in heavily pretreated patients with relapsed or refractory multiple myeloma.
The study met its primary endpoint, with arlo-cel demonstrating a statistically significant and clinically meaningful overall response rate in patients who had received at least four prior lines of therapy and were previously exposed to four major treatment classes, including BCMA-targeted therapy.
The trial also met key secondary endpoints, including complete response rate in patients treated with four or more prior lines, as well as overall and complete response rates among patients who had received at least three prior lines of therapy. Bristol Myers said arlo-cel’s safety profile was consistent with other CAR T-cell and GPRC5D-targeted therapies.
Arlo-cel is an investigational autologous CAR T-cell therapy targeting GPRC5D, a protein expressed on multiple myeloma cells independently of BCMA. This could provide an alternative treatment approach for patients whose disease has progressed following BCMA-directed therapies.
Bristol Myers plans to present detailed QUINTESSENTIAL results at an upcoming medical meeting. The company did not disclose specific response-rate percentages in the topline announcement.
Bristol Myers Squibb (NYSE: BMY) announced positive topline results from the registrational Phase 2 QUINTESSENTIAL trial evaluating arlocabtagene autoleucel, or arlo-cel, in heavily pretreated patients with relapsed or refractory multiple myeloma.
The study met its primary endpoint, with arlo-cel demonstrating a statistically significant and clinically meaningful overall response rate in patients who had received at least four prior lines of therapy and were previously exposed to four major treatment classes, including BCMA-targeted therapy.
The trial also met key secondary endpoints, including complete response rate in patients treated with four or more prior lines, as well as overall and complete response rates among patients who had received at least three prior lines of therapy. Bristol Myers said arlo-cel’s safety profile was consistent with other CAR T-cell and GPRC5D-targeted therapies.
Arlo-cel is an investigational autologous CAR T-cell therapy targeting GPRC5D, a protein expressed on multiple myeloma cells independently of BCMA. This could provide an alternative treatment approach for patients whose disease has progressed following BCMA-directed therapies.
Bristol Myers plans to present detailed QUINTESSENTIAL results at an upcoming medical meeting. The company did not disclose specific response-rate percentages in the topline announcement.
