EU Widens Approval for Bristol Myers Squibb’s Reblozyl® for First-Line LR-MDS Anemia

Bristol Myers Squibb (NYSE: BMY) has disclosed that the European Commission (EC) has broadened the approval of Reblozyl® (luspatercept) to encompass the initial treatment of adult patients grappling with transfusion-dependent anemia linked to very low, low, and intermediate-risk myelodysplastic syndromes (MDS). This extension of Reblozyl’s approval spans across all EU member states.*

Dr. Monica Shaw, Senior Vice President and Head of European Markets at Bristol Myers Squibb, expressed, “With this approval for Reblozyl as a first-line treatment for anemia in adults with lower-risk MDS, more patients in the EU will have the potential to become transfusion independent for longer periods of time compared to current options available.” She emphasized the commitment to developing novel options for patients with disease-related anemia.

The approval stems from the pivotal Phase 3 COMMANDS study, demonstrating Reblozyl’s superior efficacy compared to epoetin alfa, an erythropoiesis stimulating agent, in achieving concurrent red blood cell transfusion independence and hemoglobin increase, the study’s primary endpoint. Safety outcomes were consistent with prior MDS studies and aligned with anticipated symptoms in this patient cohort. Reblozyl is also sanctioned in the United States and Japan for the initial treatment of anemia linked with lower-risk MDS.

Dr. Matteo Giovanni Della Porta, Study Investigator and Head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy, remarked, “Results from the COMMANDS study underscore the clinical value of Reblozyl as an initial treatment for anemia in patients with low- to intermediate-risk MDS, and this approval represents a significant milestone towards improving treatment practice and offering better outcomes for patients.”

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland, and Wales).

COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndromes (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA)-naïve.

The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin (Hb) increase ≥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 ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥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 ≥24 weeks.

At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa. Results from the primary analysis of the intent to treat (ITT) population showed:

  • 60.4% (n=110) of patients receiving Reblozyl vs. 34.8% (n=63) of patients receiving epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with concurrent mean 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 74.2% (n=135) of Reblozyl patients vs. 53% (n=96) of epoetin alfa patients (p<0.0001).
  • RBC-TI of at least 12 weeks was achieved by 68.1% (n=124) of Reblozyl patients vs. 48.6% (n=88) of epoetin alfa patients (p<0.0001).
  • Duration of response was 128.1 weeks (108.3-NE) for Reblozyl in patients who achieved TI for at least 12 weeks (achieved weeks 1-24) compared to 89.7 weeks (55.9-157.3) for epoetin alfa (Hazard Ratio [HR]: 0.534; 95% Confidence Interval [CI]: 0.330-0.864, p=0.0096). Safety results were consistent with previous MDS studies, and progression to acute myeloid leukemia and total deaths were similar between both arms of the study. The most common treatment-emergent adverse events in at least 10% of patients were diarrhea, fatigue, COVID-19, hypertension, dyspnea, nausea, peripheral edema, asthenia, dizziness, anemia, back pain, and headache. Rates of reported fatigue and asthenia were shown to decrease over time.

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