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

Phase 3 trial evaluated luspatercept-aamt and shows highly statistically significant and clinically meaningful improvement in red blood cell transfusion for those with myelodysplastic syndromes.

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