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First-line superiority vs an ESA
REBLOZYL demonstrated superiority vs epoetin alfa in achieving RBC-TI with hemoglobin increase in patients with lower-risk MDS in the Phase 3 COMMANDS trial.1
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REBLOZYL is indicated for the first-line treatment of lower-risk MDS-associated anemia.1
>90% of study participants were outside of the United States and used a non-US-licensed epoetin alfa product. Direct comparisons between RELBOZYL and US-licensed epoetin alfa product have not been established.
1L=first-line; ESA=erythropoiesis-stimulating agent; MDS=myelodysplastic syndromes; RS=ring sideroblasts; sEPO=serum erythropoietin.
COMMANDS (N=356) was a Phase 3, randomized, open-label, active-controlled trial comparing REBLOZYL vs epoetin alfa in adult patients with anemia due to IPSS-R very low-, low-, or intermediate-risk MDS, with or without ring-sideroblasts, who were ESA-naive (with endogenous sEPO levels <500 U/L) and required RBCT. Patients with del(5q) and those previously treated with disease-modifying agents or HMAs were excluded.
Patients were randomized to either REBLOZYL (n=178) 1 mg/kg SC Q3W, with titration up to max 1.75 mg/kg if needed to achieve response or epoetin alfa (n=178) 450 IU/kg SC QW max total dose 40K IU, with titration up to 1050 IU/kg max total dose 80K IU. The primary endpoint was RBC-TI with a mean improvement in Hgb by at least 1.5 g/dL for any consecutive 12-week period during Weeks 1 to 24.
Primary endpoint (RBC-TI for ≥12 weeks with concurrent mean Hgb increase ≥1.5 g/dL): 58.5% (n=86/147; 95% CI: 50.1, 66.6) of patients in the REBLOZYL treatment group and 31.2% (n=48/154; 95% CI: 24.0, 39.1) of patients in the epoetin alfa treatment group achieved RBC-TI with Hgb increase during Weeks 1 to 24.
Endpoints included HI-E per IWG ≥8 weeks (Weeks 1-24): REBLOZYL 74.1% (109/147), epoetin alfa 51.3% (n=79/154); RBC-TI for 24 weeks (Weeks 1-24): REBLOZYL 47.6% (n=70/147), epoetin alfa 29.2% (n=45/154); and RBC-TI for ≥12 weeks (Weeks 1-24): REBLOZYL 66.7% (n=98/147), epoetin alfa 46.1% (n=71/154).
Other secondary endpoints included median duration (weeks) of RBC-TI ≥12 weeks (Weeks 1 to EOT): REBLOZYL 126.6 weeks (n=98/147; 95% CI: 108.3, NR), epoetin alfa 77.0 weeks (n=71/154; 95% CI: 39.0, NR).
The most common (>10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, asthenia, nausea, and dyspnea. The most common (>2%) Grade >3 adverse reactions included hypertension and dyspnea. Other clinically relevant adverse reaction reported in <5% of patients is injection-site reaction that includes erythema, pruritus, and rash.
CI=confidence interval; EOT=end of treatment; Hgb=hemoglobin; HI-E=hematologic improvement-erythroid; HMA=hypomethylating agent; IPSS-R=Revised International Prognostic Scoring System; IWG=International Working Group; QW=once a week; Q3W=once every 3 weeks; RBC=red blood cell; RBCT=red blood cell transfusion; RBC-TI-red blood cell transfusion independence; SC=subcutaneous; SD=standard deviation.