OVERALL SURVIVAL DATA

1L REBLOZYL COMMANDS trial data^1-3

COMMANDS (N=356) was a head-to-head trial that compared REBLOZYL vs EA in adult patients with anemia due to IPSS-R very low-, low-, or intermediate-risk MDS, with or without RS, 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 to max 1.75 mg/kg if needed to achieve response, or EA (n=178) 450 IU/kg SC Q1W with titration up to 1,050 IU/kg if needed (maximum total dose of 80,000 IU). Both treatments were dose modified targeting Hgb 10-12 g/dL and TI.^1-3

Primary endpoint: 58.5% of patients taking REBLOZYL achieved the primary composite endpoint of ≥12 week red blood cell TI and Hgb increase ≥1.5 g/dL (n=86/147; 95% Cl: 50.1, 66.6) vs 31.2% of patients taking EA (n=48/154; 95% Cl: 24.0, 39.1).¹

Key secondary endpoints: HI-E per IWG ≥8 wks (Wks 1-24): REBLOZYL 74.1% (n=109/147), EA 51.3% (n=79/154); RBC-TI for 24 wks (Wks 1-24): REBLOZYL 47.6% (n=70/147), EA 29.2% (n=45/154); RBC-TI for ≥12 wks (Wks 1-24): REBLOZYL 66.7% (n=98/147), EA 46.1% (n=71/154).¹

COMMANDS >3-YEAR FOLLOW-UP: MEDIAN OVERALL SURVIVAL IN THE ITT POPULATION⁴

First-line REBLOZYL: Observed overall survival data⁴

The median overall survival of REBLOZYL has not been reached⁴*

Analysis limitations⁴:

• These analyses should not be interpreted to determine treatment differences between arms in these subgroups because of limited sample size, lack of statistical hypothesis testing, and the increased probability of a false-positive finding
• Overall survival is a secondary endpoint, and analysis was not powered to show a statistically significant difference; analysis was conducted without controlling for type I error rate
• Extended follow-up is needed to confirm results and explore baseline characteristics associated with improved survival

Data cutoff date: October 2025.⁴
The median (range) duration of follow-up was 35.9 (1-73) months in the REBLOZYL arm and 30.8 (0-77) months in the epoetin alfa arm.⁴

*Median OS was calculated from an unstratified Kaplan–Meier method.^4
†HR was calculated by a stratified Cox proportional hazard model. Stratification factors were baseline RBC TB (<4, ≥4 pRBC U/8 weeks), RS status (+, −), and sEPO levels (≤200, >200 U/L). Derived stratification factors were used.⁴

COMMANDS >3-YEAR FOLLOW-UP: MEDIAN OVERALL SURVIVAL IN THE ITT POPULATION⁴

Treatment exposure and summary of safety⁴

^‡Treatment-emergent included adverse events that started on or after the first dose until 42 days after the last dose, as well as those SAEs made known to the investigator at any time thereafter that were suspected of being related to injection.^4
§Treatment-emergent EOI categories used either MedDRA version 28.0 SMQ or sub-SMQ or SOC or high-level terms or list of preferred terms. A patient was counted only once for multiple events within each EOI category.^4
‖EAIR per 100 PY was 100 times the number of patients with the specific TEAE divided by the total exposure time (in years) to the event. Exposure time was the overall treatment exposure for patients without the event and the time up to the first event start date for patients with the event.^4
¶Higher-risk category comprises high- and very high-risk categories per IPSS-R.^4
#Incidence rate per 100 PYs. PY was calculated from the treatment start date to the HR-MDS onset date or from the randomization date to AML onset date.⁴
**Progression to AML was calculated among the ITT population (REBLOZYL n=182; epoetin alfa n=181).⁴

AML=acute myeloid leukemia; CI=confidence interval; EA=epoetin alfa; EAIR=exposure-adjusted incidence rate; EMH=extramedullary hematopoiesis; EOI=event of interest; ESA=erythropoiesis-stimulating agent; Hgb=hemoglobin; HI-E=hematologic improvement-erythroid; HMA=hypomethylating agent; HR=hazard ratio; HR-MDS=higher-risk myelodysplastic syndromes; IPSS-R=International Prognostic Scoring System-Revised; ITT=intention-to-treat; IWG=International Working Group; MDS=myelodysplastic syndromes; MedDRA=Medical Dictionary for Regulatory Activities; pRBC=packed red blood cells; PY=person-year; Q1W=once a week; Q3W=once every 3 weeks; RBCT=red blood cell transfusion; RBC-TI=red blood cell transfusion independence; RS=ring sideroblasts; SAE=serious adverse event; SC=subcutaneous; sEPO=serum erythropoietin; SMQ=standardized MedDRA queries; SOC=system organ class; TB=transfusion burden; TEAE=treatment-emergent adverse event; TI=transfusion independence.

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. Data on file. BMS-REF-00730-2007. Princeton, NJ: Bristol-Myers Squibb Company; 2024. 4. Garcia-Manero G, Della Porta M, Zeidan AM, et al. Updated overall survival and long-term transfusion independence from the phase 3 COMMANDS trial in erythropoiesis-stimulating agent-naive patients with lower-risk myelodysplastic syndromes. Presented at: American Society of Clinical Oncology (ASCO) 2026 Annual Meeting. May 29-June 6, 2026. Chicago, IL. Abstract 6566.

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