Bristol Myers Squibb reports positive early results for GPRC5D-targeted CAR T therapy in multiple myeloma

Bristol Myers Squibb has reported positive topline data from the registrational Phase 2 QUINTESSENTIAL trial, testing arlocabtagene autoleucel, known as arlo-cel or BMS-986393, in adults with relapsed and refractory multiple myeloma who have already been through four drug classes of treatment. Arlo-cel is an experimental CAR T cell therapy that targets GPRC5D, a G protein coupled receptor, and would be a first-in-class option if approved. It’s given as a single infusion made from the patient’s own cells, an approach BMS positions as a distinct option for people with heavily pretreated disease.

The trial hit its primary endpoint, showing a statistically significant and clinically meaningful overall response rate among patients classified as quadruple-class exposed, meaning they’d previously received an immunomodulatory drug, a proteasome inhibitor, an anti-CD38 therapy and a BCMA-targeted therapy, after four or more prior treatment lines. QUINTESSENTIAL is notable as the first pivotal trial to study a therapy specifically in this group of quadruple-class exposed patients who’ve already been through BCMA-targeted treatment.

Arlo-cel also met the key secondary endpoint of complete response rate in that same quadruple-class exposed population, along with secondary endpoints for both overall response and complete response among patients who’d had three or more prior therapy lines. Its safety profile lined up with what’s already been seen in other CAR T therapies and other drugs targeting GPRC5D in multiple myeloma.

Lynelle Hoch, who leads BMS’s Cell Therapy Organization, said combination regimens are now common earlier in treatment, which means more multiple myeloma patients are becoming quadruple-class exposed and resistant to available therapies sooner, creating pressure for new options. She said the topline data point to a meaningful benefit for patients alongside a safety profile that matched expectations, and framed the results as evidence of BMS’s continued work in multiple myeloma, particularly in using cell therapy to target GPRC5D as an alternative to more established targets. She said the findings lay groundwork for arlo-cel to become a significant treatment choice for this group of patients who’ve already been through BCMA-targeted therapy.

Full QUINTESSENTIAL results are expected to be presented at a future medical conference.

---

---

Related Topics and Keywords

Bristol-Myers Squibb, GPRC5D-targeted CAR T therapy, multiple myeloma