| Disease characteristic |
REBLOZYL (n=178) |
Epoetin Alfa (n=178) |
|---|---|---|
| Hemoglobin (g/dL) | ||
| Median (min, max) | 7.80 (4.7, 9.2) | 7.80 (4.5, 10.2) |
| Serum EPO (U/L) | ||
| A majority of patients had sEPO levels ≤200 U/L4 | ||
| Median (min, max) | 78.7 (7.8, 495.8) | 85.9 (4.6, 462.5) |
| IPSS-R risk classification at baseline–n (%) | ||
| Very low | 16 (9.0) | 17 (9.6) |
| Low | 126 (70.8) | 131 (73.6) |
| Intermediate | 34 (19.1) | 28 (15.7) |
| High | 1 (0.6) | 0 (0) |
| Missing | 1 (0.6) | 2 (1.1) |
| Ring sideroblast status (per WHO criteria)–n (%) | ||
| RS-positive | 130 (73.0) | 128 (71.9) |
| COMMANDS had the largest number of RS- patients of any Phase 3 LR-MDS study5-7 | ||
| RS-negative | 48 (27.0) | 49 (27.5) |
| Missing | 0 (0) | 1 (0.6) |
| SF3B1 mutation status–n (%) | ||
| Mutated | 111 (62.4) | 99 (55.6) |
| Non-mutated | 65 (36.5) | 72 (40.4) |
| Missing | 2 (1.1) | 7 (3.9) |
WHY TREAT WITH REBLOZYL:
STUDY DESIGN
COMMANDS Study Design
REBLOZYL was studied head-to-head vs an ESA1
COMMANDS: A PHASE 3, OPEN-LABEL, RANDOMIZED, ACTIVE-CONTROLLED, HEAD-TO-HEAD TRIAL OF REBLOZYL VS EPOETIN ALFA IN ANEMIA DUE TO LR-MDS IN ESA-NAIVE PATIENTS1,2
Patient population (N=356)1-3
- Adults ≥18 years of age
- IPSS-R very low-, low- or intermediate-risk MDS
- RS-positive or RS-negative
- ESA-naive
- Endogenous sEPO <500 U/L
- Requiring RBC transfusions for Hgb ≤9 g/dL with symptoms or Hgb ≤7 g/dL without symptoms and 2 to 6 units of RBCs within 8 weeks prior to randomization
- Excluded: patients with del(5q) and those previously treated with disease-modifying agents or HMAs
REBLOZYL1
1 mg/kg SC Q3W, with titration up to max 1.75 mg/kg if needed to achieve response (n=178)
Epoetin Alfa2,4
450 IU/kg SC Q1W with titration up to 1,050 IU/kg if needed (maximum total dose of 80,000 IU) (n=178)
Both treatments were dose modified targeting Hgb between 10-12 g/dL and TI4
All patients received BSC, which
included RBC transfusions as needed1
Composite primary endpoint1
For any consecutive 12-week period during Weeks 1 to 24:
- RBC transfusion independenceand
- Mean improvement in Hgb by at least 1.5 g/dL
Key secondary endpoints1
- HI-E response per IWG ≥8 weeks (Weeks 1-24)
- RBC-TI for 24 weeks (Weeks 1-24)
- RBC-TI for ≥12 weeks (Weeks 1-24)
Other secondary endpoints1,2
- Mean Hgb increase ≥1.5 g/dL (Weeks 1-24)
- Duration of RBC-TI ≥12 weeks (Weeks 1-EOT)
- Time to first RBC transfusion (Weeks 1-EOT)
- Hgb change from baseline over 24 weeks (Weeks 1-24)
*>90% of study participants were outside of the United States and used a non-US-licensed epoetin alfa product. Direct comparisons between REBLOZYL and US-licensed epoetin alfa product have not been established.1
Interim analysis of COMMANDS reported.1
Baseline disease characteristics were balanced across study arms in pivotal Phase 3 COMMANDS trial1
BASELINE DISEASE CHARACTERISTICS
BSC=best supportive care; EOT=end of treatment; EPO=erythropoietin; ESA=erythropoiesis-stimulating agent; Hgb=hemoglobin; HI-E=hematologic improvement-erythroid; HMA=hypomethylating agent; IPSS-R=Revised International Prognostic Scoring System; IWG=International Working Group; LR-MDS=lower-risk myelodysplastic syndromes; MDS=myelodysplastic syndromes; NCCN=National Comprehensive Cancer Network; Q1W=once a week; Q3W=once every 3 weeks; RBC=red blood cell; RBC-TI=red blood cell transfusion independence; RS=ring sideroblast; SC=subcutaneous; sEPO=serum erythropoietin; TI=transfusion independence; WHO=World Health Organization.
See the primary endpoint and
EPO ≤200 U/L data from the study
References: 1. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2026. 2. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. Lancet. 2023;402(10399):373-385. 3. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. Lancet. 2023;402(10399)(suppl):373-385. 4. Data on file. BMS-REF-00730-2007. Princeton, NJ: Bristol-Myers Squibb Company; 2024. 5. Garcia-Manero G, Platzbecker U, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive patients with transfusion-dependent lower-risk myelodysplastic syndromes: full analysis of the COMMANDS trial. Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition. December 9-12, 2023. San Diego, CA. Abstract 193. 6. Fenaux P, Santini V, Spiriti MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658. doi:10.1038/s41375-018-0118-9 7. Greenberg PL, Sun Z, Miller KB, et al. Treatment of myelodysplastic syndrome patients with erythropoietin with or without granulocyte colony-stimulating factor: results of a prospective randomized phase 3 trial by the Eastern Cooperative Oncology Group (E1996). Blood. 2009;114(12):2393-2400. doi:10.1182/blood-2009-03-211797
