Phase III COMMANDS Trial Shows Promise of Luspatercept Across MDS Mutations

Luspatercept-aamt demonstrated “favorable outcomes” compared with epoetin alfa across common mutations in myelodysplastic syndromes (MDS), according to a news release on phase III COMMANDS trial data presented at the 2023 European Hematology Association (EHA) Congress.

The open-label, randomized trial evaluated luspatercept-aamt versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), for the treatment of anemia in adults with very low-, low- or intermediate-risk MDS who require red blood cell (RBC) transfusions and are ESA-naïve. The study’s primary endpoint was RBC transfusion independence for 12 weeks with a mean hemoglobin increase of ≥1.5 g/dL.

The 2023 EHA Congress presentation includes safety and efficacy data consistent with the results presented at the 2023 American Society of Clinical Oncology Annual Meeting by Guillermo Garcia-Manero, MD, of the University of Texas MD Anderson Cancer Center.

The data presented at EHA adds to those results by showing patients who received luspatercept-aamt had a “higher probability of achieving clinical benefit, regardless of overall mutational burden,” officials said in a news release. The investigators compared the treatments across patients with MDS who had mutations in genes including SF3B1, SF3B1a, ASXL1, TET2, DNMT3A, EZH2, IDH2, and U2AF1.

See TABLE 1 for results across the mutation type and treatment type.

“Clinical experience has demonstrated that just one in three patients with low-risk myelodysplastic syndromes experience responses to erythroid stimulating agents over six to 18 months, leaving a significant need for more effective options to address chronic anemia,” Matteo Giovanni Della Porta, MD, study investigator and head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy, said in the release. “In the COMMANDS study, the median duration of red blood cell transfusion independence was nearly one year longer with Reblozyl than with epoetin alfa and showed safety consistent with its known profile, demonstrating its potential as a first-line treatment in patients with transfusion-dependent, very low- to intermediate-risk MDS.”

Reference

Bristol Myers Squibb to present first results at ASCO and EHA from phase 3 COMMANDS study of Reblozyl® (luspatercept-aamt) in first-line treatment of anemia in adults with lower-risk myelodysplastic syndromes (MDS). Business Wire. May 25, 2023. Accessed June 7, 2023. https://www.businesswire.com/news/home/20230524005878/en/Bristol-Myers-Squibb-to-Present-First-Results-at-ASCO-and-EHA-from-Phase-3-COMMANDS-Study-of-Reblozyl%C2%AE-luspatercept-aamt-in-First-Line-Treatment-of-Anemia-in-Adults-with-Lower-Risk-Myelodysplastic-Syndromes-MDS