BMS’s Phase III Reblozyl Trial Hits Mark In First-Line, Lower-Risk Myelodysplastic Syndrome

Reblozyl (luspatercept-aamt), which Bristol Myers Squibb Company is developing in later stages under a licensing agreement with Merck & Co., Inc., stands to greatly expand the addressable population with lower-risk myelodysplastic syndromes (MDS) with positive Phase III topline results from the COMMANDS trial, even as questions remain about the drug’s durability. The potential for a US label expansion into the first-line setting from the currently approved second-line setting could also help make up for a missed opportunity earlier this year in beta-thalassemia.

While not disclosing data, BMS said 31 October that COMMANDS met its primary endpoint, showing a highly statistically significant and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent hemoglobin increase