Bristol Myers Squibb has announced the results of the Phase 3 INDEPENDENCE trial assessing Reblozyl® (luspatercept-aamt) in adult patients with myelofibrosis-associated anemia. The trial, which evaluated Reblozyl in combination with janus kinase inhibitor (JAKi) therapy for patients receiving red blood cell $(RBC)$ transfusions, did not achieve its primary endpoint of RBC transfusion independence during any 12-week period within the first 24 weeks of treatment when compared to placebo. Despite this, the results demonstrated a numerical and clinically meaningful improvement in transfusion independence favoring Reblozyl, consistent with previous Phase 2 trial findings. The study also showed significant secondary benefits, including reductions in RBC transfusion burden and increases in hemoglobin levels. Bristol Myers Squibb plans to discuss the submission of marketing applications with the FDA and EMA based on these findings. The safety profile of Reblozyl was consistent with prior reports.
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