INDICATIONS

REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

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Luspatercept-aamt (REBLOZYL®) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a first-line treatment option for symptomatic anemia in lower-risk MDS1*

EFFICACY AND SAFETY: SUBGROUPS

REBLOZYL delivered durable RBC-TI1

Durable transfusion-free time exhibited across all patients1

EFFICACY AND SAFETY: SUBGROUPS

REBLOZYL delivered durable RBC-TI1

Durable transfusion-free time exhibited across all patients1

Secondary endpoint: Median duration of RBC-TI ≥12 weeks (Week 1-EOT)


Duration of RBC-TI for ≥12 weeks2

Primary composite endpoints in 1-24 weeks for Reblozyl  vs Epoetin Alfa in Phase 3 COMMANDS trial
View data graph icon View KM Curve

Analysis limitations: Duration of RBC-TI ≥12 weeks was not powered to detect statistical significance.1

Data cutoff date: August 2022.

From the full analysis 48-week follow-up

REBLOZYL results across key subgroups2

Response rates of the preplanned subgroup analysis of RBC-TI for ≥24 weeks (Weeks 1-48)2


Preplanned subgroup analysis Preplanned subgroup analysis

Analysis limitations:

  • Subgroup analyses were performed for the primary and key secondary efficacy endpoints. Formal hypothesis testing was not performed
  • 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

P<0.0001.

Data cutoff date: September 2023.

From the full analysis

Nearly 80% of patients in COMMANDS had baseline sEPO ≤200 U/L2†

Among patients with baseline sEPO ≤200 U/L


RBC-TI for ≥12 weeks and mean Hgb increase ≥1.5 g/dL3

RBC-TI for ≥12 weeks and mean Hgb increase ≥1.5 g/dL Among patients with baseline sEPO ≤200 U/L

Duration of RBC-TI for ≥12 weeks2

Duration of RBC-TI for ≥12 weeks Among patients with baseline sEPO ≤200 U/L
View data graph icon View KM Curve

On REBLOZYL, ~38% of EPO >200 patients achieved a mean Hgb increase of ≥1.5 g/dL and TI for ≥12 weeks vs ~11% of patients on epoetin alfa. REBLOZYL patients also achieved a mean of 1 year of TI compared to patients on epoetin alfa who only experienced a mean of 0.5 years of TI.2,3

The primary endpoint for Weeks 1-24, RBC-TI ≥12 weeks with concurrent mean Hgb increase ≥1.5 g/dL, was achieved by 86 (58.5%) patients in the REBLOZYL arm versus 48 (31.2%) patients in the epoetin alfa arm (P<0.0001).4

Analysis limitations:

  • Subgroup analyses were performed for the primary and key secondary efficacy endpoints. Formal hypothesis testing was not performed
  • These analyses should not be interpreted to determine treatment differences due to limited sample size, lack of statistical hypothesis testing, and increased probability of a false-positive finding

145 patients in the REBLOZYL arm and 144 patients in the epoetin alfa arm had sEPO ≤200 U/L.2


Data cutoff date: March 2023.

From the full analysis 48-week follow-up

COMMANDS had 99 RS- patients, the most of any Phase 3, LR-MDS study3,5,6

Among RS- patients


RBC-TI for ≥12 weeks and mean Hgb increase ≥1.5 g/dL3

RBC-TI for ≥12 weeks and mean Hgb increase ≥1.5 g/dL among RS- patients

Duration of RBC-TI for ≥12 weeks2

Duration of RBC-TI for ≥12 weeks among RS- patients
View data graph icon View KM Curve
Callout DotsCallout Dots

Duration for REBLOZYL arm was not reached (NR) because >50% of patients were still transfusion independent at time of analysis2

Callout DotsCallout Dots

The primary endpoint for Weeks 1-24, RBC-TI ≥12 weeks with concurrent mean Hgb increase ≥1.5 g/dL, was achieved by 86 (58.5%) patients in the REBLOZYL arm versus 48 (31.2%) patients in the epoetin alfa arm (P<0.0001).4

Analysis limitations:

  • Subgroup analyses were performed for the primary and key secondary efficacy endpoints. Formal hypothesis testing was not performed
  • These analyses should not be interpreted to determine treatment differences due to limited sample size, lack of statistical hypothesis testing, and increased probability of a false-positive finding

Exploratory endpoint.


Data cutoff date: September 2023.

Watch clinical experts discuss treating key patient groups

Using sEPO ≤200 as a parameter in the LR-MDS treatment algorithm

George Yaghmour, MD

USC Norris Comprehensive Cancer Center & Hospital

Los Angeles, CA

Clinical response and duration in the RS- subgroups

Jamie Koprivnikar, MD

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, NJ

CI=confidence interval; EOT=end of treatment; EPO=erythropoietin; Hgb=hemoglobin; ITT=intent to treat; KM=Kaplan-Meier; LR-MDS=lower-risk myelodysplastic syndromes; MDS=myelodysplastic syndromes; RBC=red blood cell; RBC-TI=red blood cell transfusion independent; RS=ring sideroblast; sEPO=serum erythropoietin; TB=transfusion burden; TI=transfusion independence.

References: 1. 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 (supplementary appendix). Lancet. 2023; published online June 10, 2023. https://doi.org/10.1016/S0140-6736(23)00874-7 2. 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. 3. Data on file. BMS-REF-ACE-536-00689. Princeton, NJ: Bristol-Myers Squibb Company; 2024. 4. REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2024. 5. Fenaux P, Santini V, Spiriti MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-a in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658. 6. 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;144(12):2393-2400.