Bristol Myers Squibb’s Reblozyl Meets Primary Endpoints as First-Line Treatment of MDS

The phase 3 COMMANDS trial (NCT03682536), evaluating luspatercept-aamt (Reblozyl; Bristol Myers Squibb), met its primary endpoint of 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 for individuals with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) who require RBC transfusions.¹

Additionally, the safety results were consistent with the safety profile previously demonstrated in the MEDALIST study (NCT02631070). No new safety signals were reported.¹

“While advancements have been made in the treatment of anemia for patients with [MDS], there remains a significant need for new and better first-line treatment options for patients with transfusion-dependent MDS,” Noah Berkowitz, MD, PhD, senior vice president of hematology development at Bristol Myers Squibb, said in a statement. “We are pleased with the positive results of the COMMANDS study and look forward to presenting these important data.”¹

The results were based on a pre-specified interim analysis that was conducted by an independent review committee.¹

Key secondary endpoints of the study included RBC-TI for 24 weeks, RBC-TI of 12 weeks or more, and erythroid response of at least 8 weeks during weeks 1 through 14 of the study.¹

Bristol Myers Squibb will complete a full evaluation of the data and present detailed results at an upcoming medical meeting, as well as discuss the results with health authorities.¹

Luspatercept-aamt is being developed and commercialized in collaboration with Merck, following its acquisition of Acceleron Pharma Inc, in November 2021.¹

The drug is approved in the United States as treatment for anemia in adults with beta thalassemia who require regular RBC transfusions and anemia failing an erythropoiesis-stimulating agent and requiring 2 or more RBC units over 8 weeks in adults with very low-to-intermediate-risk MDS with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with sideroblasts and thrombocytosis.¹

RBC red blood cell transfusions in individuals who require immediate correction of anemia.¹

MDS are a group of blood disorders characterized by the abnormal development of RBC in the bone marrow.²

Symptoms include, bleeding, bruising, dizziness, fatigue, frequent infections, headaches, and weakness, according to the National Cancer for Advancing Translational Sciences.²

MDS has the possibility to progress to bone marrow failure or even develop into acute leukemia. It is estimated that fewer than 50,000 individuals in the United States have MDS.²

References

1. Bristol Myers Squibb announces positive topline results of phase 3 COMMANDS trial. News release. Bristol Myers Squibb. October 31, 2022. Accessed November 1, 2022. https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-of-Phase-3-COMMANDS-Trial/default.aspx

2. Myelodyplastic syndromes. National Cancer for Advancing Translational Sciences. Updated November 8, 2021. Accessed November 1, 2022. https://rarediseases.info.nih.gov/diseases/7132/myelodysplastic-syndromes