On September 8, 2026 Bristol Myers Squibb (NYSE: BMY) reported positive Phase 2 results from the registrational QUINTESSENTIAL trial (NCT06297226) 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.

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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.

"As combination treatment regimens are now frequently used in earlier lines of therapy, an increasing number of people with multiple myeloma are quadruple-class exposed and resistant to currently available therapies earlier in the treatment journey, creating a critical need for new therapeutic approaches," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. "These topline results support arlo-cel’s potential benefit for patients while showing a safety profile consistent with expectations. They underscore our continued innovation in multiple myeloma and highlight the value of targeting alternative proteins, like GPRC5D, with the power of cell therapy to transform outcomes, laying the foundation for arlo-cel to become an important treatment option for this emerging group of patients who have been exposed to prior BCMA-targeted therapies."

Bristol Myers Squibb thanks the patients and investigators who are participating in the QUINTESSENTIAL clinical trial. Results from QUINTESSENTIAL will be presented at an upcoming medical meeting.

* The treatment process includes collection of T cells from the patient’s blood followed by bridging therapy, CAR T cell manufacturing, lymphodepleting chemotherapy and then arlo-cel administration and side-effect monitoring.

About QUINTESSENTIAL
QUINTESSENTIAL (NCT06297226) 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.

The primary endpoint of the study is overall response rate (ORR), defined as best overall response (BOR) of partial response (PR) or better in quadruple-class exposed patients who had received four or more prior lines of therapy. Key secondary endpoints include complete response rate (CRR) in patients with RRMM who had been quadruple-class exposed after four or more prior lines of therapy, and ORR and CRR in quadruple-class exposed patients who had received three or more prior lines of therapy.

About Arlocabtagene Autoleucel
Arlocabtagene autoleucel (arlo-cel; BMS-986393) is a potential first-in-class autologous G protein-coupled receptor class C group 5 member D (GPRC5D)-directed chimeric antigen receptor (CAR) T cell therapy. GPRC5D is a receptor expressed on plasma cells in multiple myeloma, with limited expression on healthy cells, and is a validated therapeutic target in multiple myeloma. Its expression is independent of BCMA expression and is maintained even after prior BCMA-directed therapy. Arlo-cel is designed to recognize and bind to GPRC5D in order to target and eliminate GPRC5D-expressing myeloma cells.

(Press release, Bristol-Myers Squibb, SEP 8, 2026, View Source;-/default.aspx [SID1234670617])