Bristol makes a quick pivotal move in multiple myeloma

Just months after reporting promising efficacy data in a phase 1 study of BMS-986393, Bristol Myers Squibb has unveiled plans to take this anti-GPRC5D Car-T therapy into pivotal development. The Quintessential-2 study, against Darzalex, Pomalyst, Kyprolis plus dexamethasone in second to fourth-line multiple myeloma, is to begin in February, a new listing on the clinicaltrials.gov registry reveals. The move is significant not only for its speed, but also because the company has made cuts elsewhere in its multiple myeloma pipeline, most notably discontinuing a phase 3 anti-BCMA T-cell engager, alnuctamab, citing changed business objectives and an “evolving landscape”; this appeared to be a clear reference to the large number of approved anti-BCMA drugs, most importantly the Car-T therapies Carvykti and Abecma, and the T-cell engagers Tecvayli and Elrexfio. The GPRC5D space is somewhat less crowded, though Johnson & Johnson’s Talvey (another T-cell engager) is approved. In phase 1 BMS-986393 yielded an 88% ORR and 48% CR rate – better than Talvey on a cross-trial basis – though one patient died from drug-related cytokine release. Bristol is separately continuing to develop BMS-986453, a Car-T therapy that intriguingly hits BCMA as well as GPRC5D.

Selected Bristol work in multiple myeloma

Source: OncologyPipeline.