Bristol Myers Squibb has had a whiplash change of heart on its BCMA bispecific T-cell engager, halting (PDF) further development months after filing to run a phase 3 trial. The Big Pharma disclosed the change of plan alongside a phase 3 win for a potential challenger to Regeneron, Sanofi and Takeda.
BMS added a phase 3 study of the bispecific, alnuctamab, to ClinicalTrials.gov in January. At the time, the company planned to enroll 466 patients to show whether the candidate could improve progression-free survival in people with relapsed or refractory multiple myeloma. However, BMS abandoned the study within months of the initial filing.
The drugmaker withdrew the study in May, on the grounds that “business objectives have changed,” before enrolling any patients. BMS delivered the final blow to the program in its second-quarter results Friday when it reported an impairment charge resulting from the decision to discontinue further development.
A spokesperson for BMS framed the action as part of the company’s work to focus its pipeline on assets that it “is best positioned to develop” and prioritize investment in opportunities where it can deliver the “highest return for patients and shareholders.” Alnuctamab no longer meets those criteria.
“While the science remains compelling for this program, multiple myeloma is an evolving landscape and there are many factors that must be considered when prioritizing to make the biggest impact,” the BMS spokesperson said. The decision comes shortly after recently installed BMS CEO Chris Boerner began a $1.5 billion cost-cutting program.
Axing alnuctamab gets BMS out of the competitive BCMA bispecific space, which is already served by Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio. Physicians can also choose from other modalities that target BCMA, including BMS’ own CAR-T cell therapy Abecma. BMS’ multiple myeloma pipeline is now focused on the CELMoD agents iberdomide and mezigdomide and the GPRC5D CAR-T BMS-986393.
BMS also used its second-quarter results to report that a phase 3 trial of cendakimab in patients with eosinophilic esophagitis met both co-primary endpoints. The antibody hits IL-13, one of the interleukins targeted by Regeneron and Sanofi’s blockbuster Dupixent. The FDA approved Dupixent in the indication in 2022. Takeda’s once-rejected Eohilia won approval in the setting in the U.S. earlier this year.
Cendakimab could give physicians a third option. BMS said the phase 3 study linked the candidate to statistically significant reductions versus placebo in days with difficult swallowing and counts of the white blood cells that drive the disease. Safety was consistent with the phase 2 trial, according to BMS.