Luspatercept achieved primary and key secondary endpoints in phase III 'MEDALIST' study in patients with low-to-intermediate risk myelodysplastic syndromes- Celgene + Acceleron Pharma.

Celgene Corporation and Acceleron Pharma Inc. 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 MEDALIST evaluated the efficacy and safety of luspatercept versus placebo in patients with IPSS-R very low, low or intermediate risk myelodysplastic syndromes (MDS) with chronic anemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent (ESA), ring sideroblast-positive and require frequent RBC (red blood cell) 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.