Results from Phase 3 COMMANDS study, selected for ASCO\u2019s official press program,<\/i>show nearly twice as many patients treated with <\/i>Reblozyl achieved superior transfusion independence with concurrent hemoglobin increase vs. epoetin alfa, including in clinically relevant subgroups<\/i><\/b><\/p>\n
Reblozyl demonstrated a durable response, with nearly 2.5 years median transfusion independence, 1 year longer than epoetin alfa<\/i><\/b><\/p>\n
Additional results, to be presented during the plenary session at the European Hematology Association Congress, show <\/i>Reblozyldemonstrated clinical benefit across patients with spectrum of MDS mutations<\/i><\/b><\/p>\n
PRINCETON, N.J.–(BUSINESS WIRE<\/a>)–Bristol Myers Squibb<\/a> (NYSE: BMY) today announced first results from the Phase 3 COMMANDS study, an open-label, randomized trial evaluating Reblozyl<\/i>\u00ae<\/sup>(luspatercept-aamt)versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), for the treatment of anemia in adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require red blood cell (RBC) transfusions and are ESA-na\u00efve. Results from the study will be featured as part of the press program at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 3 p.m. EDT (Abstract #7003), and in an oral presentation of select abstracts during a plenary session at the European Hematology Association (EHA) Congress on June 10, 2:45 p.m. CEST (Abstract #S102).<\/p>\n \n\u201cChronic anemia, low hemoglobin levels and transfusion dependency are the primary clinical challenges for patients with lower-risk MDS, increasing the risk of death by more than half compared to those who do not require transfusions,\u201d said Guillermo Garcia-Manero, M.D., lead investigator and Chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center. \u201cResults from the COMMANDS study showed treatment with Reblozyl <\/i>compared to epoetin alfaled to superior and statistically significant improvements in red blood cell transfusion independence and hemoglobin increase, improvements in response durability, and equal or better outcomes across all subgroups, with acceptable safety and tolerability for patients with ESA-na\u00efve, lower-risk MDS.\u201d<\/p>\n \nThe primary endpoint evaluated in the COMMANDS study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin increase of \u22651.5 g\/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI \u226512 weeks and RBC-TI for 24 weeks. Eligible patients were \u226518 years old with lower-risk MDS who require transfusions. Patients were randomized 1:1 to receive subcutaneous Reblozyl<\/i> (starting dose 1.0 mg\/kg, titration up to 1.75 mg\/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU\/kg, titration up to 1050 IU\/kg) weekly for \u226524 weeks.<\/p>\n COMMANDS Study Results at ASCO
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<\/span><\/i>At the time of the interim analysis, 147 evaluable patients received Reblozyl <\/i>and 154 evaluable patients received epoetin alfa, with median treatment durations of 41.6 and 27 weeks, respectively. Results showed 58.5% (n=86) of patients receiving Reblozyl<\/i> vs. 31.2% (n=48) of patients receiving epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with concurrent mean hemoglobin (Hb) increase of at least 1.5 g\/dL within the first 24 weeks (p<0.0001). HI-E increase of at least 8 weeks was achieved by 74.1% (n=109) of Reblozyl<\/i> patients vs. 51.3% (n=79) of epoetin alfa patients (p<0.0001). Patients treated with Reblozyl<\/i> achieved more durable responses vs. epoetin alfa, with a median duration of response of RBC-TI \u226512 weeks (Week 1 to end of treatment) of 126.6 vs. 77 weeks. Within the first 24 weeks of treatment, RBC-TI of at least 24 weeks was achieved by 47.6% (n=70) of Reblozyl<\/i> patients vs. 29.2% (n=45) of epoetin alfa patients (P=0.0006). Benefit with Reblozyl <\/i>was also observed in clinically relevant subgroups, and results showed a consistent safety profile and no new safety signals.<\/p>\n
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