INDICATIONS

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

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

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REBLOZYL EFFICACY IN ESA-NAIVE PATIENTS

"Now Approved" bubble
"Now Approved" bubble

In a head-to-head study vs epoetin alfa,* REBLOZYL provides…

Unprecedented superior efficacy. Lasting transfusion independence.1,2

1L=first line; ESA=erythropoiesis-stimulating agent; MDS=myelodysplastic syndromes; RS=ring sideroblast.

*>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.

REBLOZYL EFFICACY IN ESA-NAIVE PATIENTS

"Now Approved" bubble
"Now Approved" bubble

In a head-to-head study vs epoetin alfa,* REBLOZYL provides…

Unprecedented superior efficacy. Lasting transfusion independence.1,2

1L=first line; ESA=erythropoiesis-stimulating agent; MDS=myelodysplastic syndromes; RS=ring sideroblast.

*>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.

COMMANDS—a head-to-head clinical trial of REBLOZYL vs epoetin alfa1

REBLOZYL is the only agent to be studied head-to-head against an ESA for
MDS-associated anemia1-3

COMMANDS: a Phase 3 open-label, randomized, active-controlled trial of REBLOZYL vs epoetin alfa in anemia due to LR-MDS for ESA-naive patients

*>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.

Interim analysis of COMMANDS reported.

BSC=best supportive care; EOT=end of treatment; HMA=hypomethylating agent; Hgb=hemoglobin; IPSS-R=Revised International Prognostic Scoring System; IWG=International Working Group; LR-MDS=lower-risk myelodysplastic syndromes; QW=once a week; Q3W=every 3 weeks; RBC=red blood cell; RBC-TI=red blood cell transfusion independent; RS=ring sideroblasts; SC=subcutaneous; sEPO=serum erythropoietin.

Balanced across study arms in pivotal Phase 3 COMMANDS trial1

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)
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)
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)

EPO=erythropoietin; RBC=red blood cell; RS=ring sideroblasts; WHO=World Health Organization.

REBLOZYL demonstrated superiority with nearly 2X
the patients achieving RBC-TI with Hgb increase vs epoetin alfa1

Primary composite endpoint: RBC-TI for at least 12 weeks with concurrent mean Hgb increase ≥1.5 g/dL1


Primary Endpoint REBLOZYL® vs epoetin alfa graph Primary Endpoint REBLOZYL® vs epoetin alfa graph

This prespecified interim analysis included 301 patients who had either completed 24 weeks of treatment or discontinued prior to completing 24 weeks of treatment. This represents 85% of the total patient population contributing data for the primary endpoint.1

Key secondary 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).1,2

CI=confidence interval; Hgb=hemoglobin.

69% of all COMMANDS patients receiving REBLOZYL
had their dose increased at least once4

Responders on REBLOZYL had lasting transfusion independence3

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

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


Median duration of RBC-TI ≥12 weeks graph
Median duration of RBC-TI ≥12 weeks graph

CI=confidence interval; EOT=end of treatment; NR=not reached; RBC-TI=red blood cell transfusion independence.

References: 1.REBLOZYL [US Prescribing Information]. Summit, NJ: Celgene Corporation; 2023. 2. Platzbecker U, Della Porta MG, Santini V, et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naïve, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomized 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-naïve, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomized controlled trial. Lancet. 2023;402(10399)(suppl):373-385. 4. Data on file package: BMS-REF-ACE-536-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2023.

2007-US-2300137     08/2023