Bristol Myers Squibb's investigational GPRC5D-directed CAR T-cell therapy arlo-cel met the primary and key secondary endpoints in the Phase 2 QUINTESSENTIAL trial for heavily pretreated multiple myeloma patients. The study enrolled quadruple-class exposed patients who had previously received BCMA-targeted therapy, marking the first pivotal trial in this population.
Bristol Myers Squibb's arlo-cel met primary and key secondary endpoints in a Phase 2 trial for quadruple-class exposed multiple myeloma patients.
"The results highlight the potential of targeting alternative proteins like GPRC5D to transform outcomes for patients who have already been exposed to BCMA therapies," Lynelle Hoch, president of Bristol Myers Squibb's Cell Therapy Organization, said.
The QUINTESSENTIAL trial enrolled adults with relapsed or refractory multiple myeloma who had received four or more prior lines of treatment, including an immunomodulatory drug, a proteasome inhibitor, an anti-CD38 therapy and a BCMA-targeted therapy. The study met its primary endpoint of overall response rate, described as statistically significant and clinically meaningful, and the key secondary endpoint of complete response rate. Additional endpoints evaluating ORR and CRR in patients with at least three prior lines were also met. Specific response percentages were not disclosed; more detailed results are expected at an upcoming medical meeting.
Arlo-cel (BMS-986393) is a single-infusion autologous CAR T-cell therapy targeting GPRC5D, a protein whose expression is independent of BCMA. The company said QUINTESSENTIAL is the first pivotal trial to evaluate a therapy in this quadruple-class exposed population following prior BCMA-targeted treatment. The safety profile was consistent with other CAR T-cell therapies and GPRC5D-targeting approaches in multiple myeloma, though specific rates of individual side effects were not included in the topline announcement.
The readout strengthens Bristol Myers Squibb's cell therapy franchise as the company faces revenue pressure from patent expirations on key products. Bristol Myers Squibb, a US biopharmaceutical group with a US$136.5 billion market cap, has not yet filed arlo-cel with the FDA. The therapy remains investigational and has not been evaluated by the agency as safe or effective for multiple myeloma.
BMY shares closed at $64.69 on Tuesday, down 3.19 percent. The stock has traded between $42.52 and $68.64 over the past year.
The positive data gives Bristol Myers Squibb a potential new option in the competitive multiple myeloma field, where Johnson & Johnson and other rivals have established BCMA-directed CAR-T therapies. If arlo-cel advances to regulatory filing and approval, it could provide a differentiated treatment for patients who become resistant to BCMA-targeted therapies. Investors will watch for detailed efficacy and safety data at the upcoming medical meeting, along with any regulatory filing timeline.
This article is for informational purposes only and does not constitute investment advice.
