Acceleron, Celgene complete enrollment in Phase III of luspatercept in MDS

Acceleron Pharma Inc. (NASDAQ:XLRN) and Celgene Corp. (NASDAQ:CELG) completed enrollment of 210 patients with ring sideroblasts (RS+), lower-risk myelodysplastic syndrome (MDS) in the Phase III MEDALIST trial evaluating subcutaneous luspatercept (ACE-536) every 3 weeks for 48 weeks. The companies expect top-line data from the double-blind, placebo-controlled, international trial in mid-2018.

The primary endpoint is proportion of patients achieving transfusion independence for 8 consecutive weeks through week 24. Secondary endpoints include change in red blood cells transfused, proportion of patients achieving hematologic improvement and mean hemoglobin increase, time to and duration of transfusion independence, change in serum ferritin and iron chelation therapy use, time to and number of patients progressing to acute myelogenous leukemia (AML), overall survival (OS), safety, anti-drug antibodies and pharmacokinetics...