2022-10-31| Trials & Approvals

Bristol Myers Squibb Releases Promising Preliminary Anemia Clinical Trial Results

by Max Heirich
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Bristol Myers Squibb (BMS) announced results from their Phase 3, open-label clinical trial, the COMMANDS study. The study evaluated Reblozyl (luspatercept-aamt), a therapeutic option for red blood cell maturation. COMMANDS met its primary endpoint, showing improvement in red blood cell transfusion in adult patients with myelodysplastic syndromes.

With the results, BMS will move forward with a full evaluation of the study. 

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Promising Results of a Shared Treatment

Myelodysplastic syndromes are a classification of disorders characterized by blood cells that are poorly formed or don’t work properly. These disorders result from a mistake in bone marrow, the area of the body where white blood cells form. 

Developed and commercialized in collaboration with Merck after its acquisition of Acceleron Pharma, Inc. in November 2021, Reblozyl is potentially a treatment for Myelodysplastic syndromes. Previously, the United States Food and Drug Administration (FDA) approved Reblozyl as a treatment for anemia in adult patients with beta-thalassemia who need regular red blood cell transfusions.

The COMMANDS trial evaluated the efficacy and safety of Reblozyl against epoetin alfa for the treatment of anemia due to myelodysplastic syndrome. An independent review committee reviewed the trial, finding that Reblozyl met its primary endpoint, demonstrating a highly significant and meaningful improvement in red blood cell transfusion independence.

On the results, Noah Berkowitz, M.D., Ph.D., senior vice president of Hematology Development at Bristol Myers Squibb, said, “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. We are pleased with the positive results of the COMMANDS study and look forward to presenting these important data.”

Going forward, Bristol Myers Squibb will conduct a full evaluation of the COMMANDS data in collaboration with investigators. They intend the full publishing of their findings at “an upcoming medical meeting.” 

Due to the success of the COMMANDS trial, in addition to Reblozyl’s prior approvals, an approval for myelodysplastic syndrome-caused anemia is a genuine possibility. 

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