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Bristol Myers Squibb Announces Positive Topline Results of Phase 3 COMMANDS Trial

Tuesday, November 01, 2022

Bristol Myers Squibb announced the COMMANDS study, a Phase 3, open-label, randomized trial evaluating Reblozyl®(luspatercept-aamt), met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent hemoglobin (Hb) increase in the first-line treatment of adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require RBC transfusions. This result was based on a pre-specified interim analysis conducted through an independent review committee. Safety results in the trial were consistent with the safety profile of Reblozyl previously demonstrated in the MEDALIST study (NCT02631070), and no new safety signals were reported.

“While advancements have been made in the treatment of anemia for patients with myelodysplastic syndromes, there remains a significant need for new and better first-line treatment options for patients with transfusion-dependent MDS,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “We are pleased with the positive results of the COMMANDS study and look forward to presenting these important data.”

Bristol Myers Squibb will complete a full evaluation of the COMMANDS data and work with investigators to present detailed results at an upcoming medical meeting, as well as discuss these results with health authorities. Bristol Myers Squibb thanks the patients and investigators who are participating in the COMMANDS clinical trial.

Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.

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