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 Announces Positive Topline Results from Registrational Phase 2 QUINTESSENTIAL Trial of the Potential First-in-Class GPRC5D-Directed CAR T Cell Therapy, Arlocabtagene Autoleucel, in Patients with Quadruple-Class Exposed Relapsed and Refractory Multiple Myeloma

Bristol Myers Squibb (NYSE: BMY) today announced 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.

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.”

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