Phase III COMMANDS study of Reblozyl in myelodysplastic syndromes reported at ASCO and EHA meetings.- BMS
Bristol Myers Squibb announced first results from the Phase III COMMANDS study, an open-label, randomized trial evaluating Reblozyl (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-naïve. Results from the study will be featured at the American Society of Clinical Oncology (ASCO) Annual Meeting and in an oral presentation of select abstracts during a plenary session at the European Hematology Association (EHA) Congress.
The primary endpoint evaluated in the COMMANDS study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI at least 12 weeks and RBC-TI for 24 weeks. Eligible patients were at least 18 years old with lower-risk MDS who require transfusions. Patients were randomized 1:1 to receive subcutaneous Reblozyl (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 at least 24 weeks.
At the time of the interim analysis, 147 evaluable patients received Reblozyl 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 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 patients vs. 51.3% (n="79)" of epoetin alfa patients (p><0.0001). patients treated with reblozyl achieved more durable responses vs. epoetin alfa, with a median duration of response of rbc-ti at least 12 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 patients vs. 29.2% (n="45)" of epoetin alfa patients (p="0.0006)." benefit with reblozyl was also observed in clinically relevant subgroups, and results showed a consistent safety profile and no new safety signals.></0.0001).></0.0001).>
A supplemental Biologics License Application for Reblozyl is currently under Priority Review with the FDA for treatment of anemia in ESA-naive adult patients with very low- to intermediate-risk MDS who may require RBC transfusions with an assigned Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2023. The European Medicines Agency has also validated the Type II Variation for Reblozyl in this patient population. Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins