Positive topline results from the Phase 2 QUINTESSENTIAL trial showed arlocabtagene autoleucel (arlo-cel) met the study’s primary and key secondary efficacy endpoints in patients with heavily pretreated, relapsed and refractory multiple myeloma (RRMM).
On Tuesday, September 8, Bristol Myers Squibb (BMS) announced positive topline results from the registrational Phase 2 QUINTESSENTIAL trial (NCT06297226) in a press release.
The QUINTESSENTIAL trial is “a Phase 2, open-label, multicenter, single-arm study evaluating the efficacy and safety of arlocabtagene autoleucel (arlo-cel; BMS986393) in patients with quadruple-class exposed relapsed and refractory multiple myeloma (RRMM).”
“Quadruple-class exposed consists of those who have been treated with an immunomodulatory inhibitor (IMiD), a proteasome inhibitor (PI), an anti-CD38 therapy and a BCMA-targeted therapy. The trial included patients who had received prior treatment with CAR T cell therapies,” stated BMS in its press release.
Arlo-cel is an investigational, autologous GPRC5D-directed chimeric antigen receptor T cell (CAR T) therapy designed to identify and eliminate myeloma cells expressing GPRC5D. The protein is expressed on plasma cells involved in multiple myeloma and has limited expression on healthy cells.
Importantly, GPRC5D expression is independent of BCMA and can remain present after treatment targeting BCMA, providing a potential therapeutic option for patients whose disease has progressed following BCMA-directed therapy.
According to BMS, arlo-cel met the study’s primary and key secondary efficacy endpoints in patients with heavily pretreated, relapsed and refractory multiple myeloma (RRMM).
The trial met its primary endpoint by showing a statistically significant and clinically meaningful overall response rate (ORR) among patients with quadruple-class exposed RRMM who had received at least four prior lines of therapy.
Arlo-cel also met the key secondary endpoint of complete response rate (CRR) in this patient population. The study additionally met its key secondary endpoints for ORR and CRR among quadruple-class exposed patients who had received at least three prior lines of therapy.
The safety profile of arlo-cel was described as consistent with known safety profiles of other CAR T cell therapies and GPRC5D-targeting treatments used in multiple myeloma. Full results are expected to be presented at an upcoming medical meeting.
Arlo-cel is intended to be administered as a single infusion after a treatment process that includes collecting the patient’s T cells, potential bridging therapy, manufacturing the personalized CAR T cells, lymphodepleting chemotherapy and subsequent infusion and monitoring for side effects. BMS describes the therapy as a potential first-in-class GPRC5D-directed CAR T cell treatment.
Reference:
Bristol Myers Squibb Announces Positive Topline Results from Registrational Phase 2 QUINTESSENTIAL Trial of the Potential First-in-Class GPRC5D-Directed CAR T Cell Therapy, Arlocabtagene Autoleucel. Bristol Myers Squibb press release. September 8, 2026.