Celgene, Acceleron have positive results in Phase 3 blood disorder med study

Celgene (CELG) and Acceleron Pharma (XLRN) announced results from a phase III, randomized, double-blind, multi-center clinical study (MEDALIST). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of red blood cell transfusion independence of at least 8 consecutive weeks during the first 24 weeks compared to placebo. MEDALIST evaluated the efficacy and safety of luspatercept versus placebo in patients with IPSS-R very low, low or intermediate risk myelodysplastic syndromes with chronic anemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent, ring sideroblast-positive and require frequent RBC transfusions. In addition to achieving the primary endpoint of the study, luspatercept also met the key secondary endpoint of demonstrating a highly statistically significant improvement in RBC transfusion independence of at least 12 consecutive weeks during the first 24 weeks. Modified hematologic improvement-erythroid (IWG mHI-E), a meaningful secondary endpoint, was also achieved. Adverse events observed in the study were generally consistent with previously published data.

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