Bristol Myers Squibb & Co. (NYSE:BMY) on Friday announced topline results from the Phase 3 INDEPENDENCE trial evaluating Reblozyl (luspatercept-aamt) with concomitant janus kinase inhibitor (JAKi) therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusions.
The study 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 (p=0.0674).
Patients saw a numerical and clinically meaningful improvement in RBC transfusion independence favoring Reblozyl, in line with previous results from the Phase 2 trial.
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Several key secondary measures also showed a clinically meaningful benefit favoring Reblozyl, which included a higher number of patients who achieved at least a 50% reduction (and by at least 4 RBC units) in RBC transfusion burden, as well as a higher number of patients achieving a hemoglobin (Hb) 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 Reblozyl’s previously reported safety profile across indications. The company will engage with the FDA and EMA to discuss the submission of marketing applications.
Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require RBC transfusions, failing an erythropoiesis stimulating agent and requiring two or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, and treatment of anemia in adult patients with beta thalassemia who require RBC transfusions.
Price Action: BMY stock is trading lower by 1.40% to $47.39 at last check Friday.
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