Reblozyl Shows Promise as First-Line Treatment for Myelodysplastic Syndromes in Phase 3 Trial

Key Insights

• Bristol Myers Squibb's Reblozyl demonstrated statistically significant and clinically meaningful improvements in red blood cell transfusion independence in a Phase 3 trial for myelodysplastic syndromes.
• The COMMANDS study evaluated Reblozyl versus epoetin alfa in transfusion-dependent, erythropoiesis stimulating agent-naïve patients with very low-, low-, and intermediate-risk myelodysplastic syndromes.
• Reblozyl met the primary endpoint of red blood cell transfusion independence for 12 weeks and key secondary endpoints, including transfusion independence at 24 weeks.

Bristol Myers Squibb (BMS) has announced positive topline results from the Phase 3 COMMANDS trial, evaluating Reblozyl (luspatercept-aamt) as a first-line treatment for patients with very low-, low-, and intermediate-risk myelodysplastic syndromes (MDS). The study met its primary and key secondary endpoints, demonstrating a statistically significant and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent hemoglobin (Hb) increase.

The COMMANDS study (NCT03682536) was an open-label, randomized trial comparing Reblozyl to epoetin alfa in adult patients with IPSS-R MDS who require RBC transfusions and are erythropoiesis stimulating agent (ESA) naïve. The primary endpoint was RBC-TI for at least 12 weeks, while secondary endpoints included RBC-TI for at least 24 weeks and erythroid response of at least eight weeks during weeks one to 24 of the study.

Myelodysplastic syndromes are a group of closely related blood cancers characterized by ineffective production of healthy red blood cells, white blood cells, and platelets, leading to anemia and increased susceptibility to infections. Patients with MDS-related anemia often require regular blood transfusions to maintain adequate red blood cell counts. However, frequent transfusions can result in iron overload, transfusion reactions, and infections.

The positive results from the COMMANDS trial offer a potential new first-line treatment option for patients with transfusion-dependent MDS. According to Dr. Noah Berkowitz, senior vice president, hematology department at Bristol Myers Squibb, "While advancements have been made in the treatment of anaemia for patients with myelodysplastic syndromes, there remains a significant need for new and better first-line treatment options for patients with transfusions-dependent MDS."

The safety profile of Reblozyl in the COMMANDS trial was consistent with previous findings from the MEDALIST study (NCT02631070). BMS plans to conduct a full evaluation of the COMMANDS data and present detailed results at an upcoming medical meeting, followed by discussions with health authorities. Reblozyl is being developed and commercialized through a global collaboration between BMS and Merck, following Merck’s acquisition of Acceleron Pharma, Inc., in November 2021.