Bristol Myers says Phase 3 INDEPENDENCE trial for Reblozyl did not meet endpoint

Bristol Myers (BMY) Squibb announced the Phase 3 INDEPENDENCE trial evaluating Reblozyl with concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell transfusions did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within the first 24 weeks of treatment, compared to placebo. Patients saw a numerical and clinically meaningful improvement in RBC transfusion independence favoring Reblozyl, in line with previous results from the Phase 2 trial. Several important secondary measures also showed a clinically meaningful benefit favoring Reblozyl, which included a higher number of patients who achieved at least a 50% reduction in RBC transfusion burden, as well as a higher number of patients achieving a hemoglobin level increase by at least 1 g/dL while remaining transfusion independent for at least 12 consecutive weeks. Frequently observed treatment emergent adverse events were consistent with the known safety profile of Reblozyl previously reported across indications. The company is encouraged by the clinically meaningful results of the study and will engage with the FDA and EMA to discuss the submission of marketing applications.