WHY TREAT WITH REBLOZYL:
PRIMARY ENDPOINT AND EPO ≤200 U/L RESULTS

REBLOZYL can replace epoetin alfa in first-line LR-MDS, including in patients with EPO ≤200 U/L1

The head-to-head COMMANDS trial measured the percentage of patients who achieved BOTH a 1.5 g/dL Hgb increase AND ≥12 weeks of transfusion independence2*†

REBLOZYL was studied head-to-head against EA in adult patients with anemia due to LR-MDS who were ESA-naive and required transfusions. 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% CI: 50.1, 66.6) vs 31.2% of patients taking EA (n=48/154; 95% Cl: 24.0, 39.1).2

PREPLANNED EPO ≤200 U/L SUBGROUP ANALYSIS (DURING WKS 1-24)1

Response rate of REBLOZYL (n=96/145): 66.2% vs Epoetin Alfa (n=59/144): 41.0% in EPO less than or equal to 200 U/L subgroup.

Historically, low serum EPO was a predictor of ESA response3

Now we can see, patients with low serum
EPO are appropriate for REBLOZYL1

*For any consecutive 12-week period during Weeks 1-24.2

†Defined as the absence of any RBC transfusion during any consecutive 12-week period.2

Preplanned EPO >200 to <500 U/L subgroup analysis (during wks 1-24)1:

37.8% of REBLOZYL patients (n=14/37) vs 10.8% of epoetin alfa patients (n=4/37) achieved the primary endpoint.

Analysis limitations of response rates by baseline sEPO4:

These preplanned subgroup analyses should not be interpreted to determine treatment differences between arms in these subgroups due to limited sample size, lack of statistical hypothesis testing, and increased probability of a false-positive finding.

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

PRIMARY COMPOSITE ENDPOINT: INTENT TO TREAT INTERIM ANALYSIS (DURING WKS 1-24)2‡

REBLOZYL has nearly 2x the response rate vs epoetin alfa.

‡Common rate difference (95% CI): 26.6 (15.8, 37.4) P<0.0001.2

Other key secondary endpoints2:

  • 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)

CI=confidence interval; EA=epoetin alfa; EPO=erythropoietin; ESA=erythropoiesis-stimulating agent; Hgb=hemoglobin; HI-E=hematologic improvement-erythroid; IWG=International Working Group; LR-MDS=lower-risk myelodysplastic syndromes; Q3W=once every 3 weeks; RBC=red blood cell; RBC-TI=red blood cell transfusion independence; sEPO=serum erythropoietin; TI=transfusion independence.

REBLOZYL HCP

See the safety data for REBLOZYL

References: 1. Della Porta MG, Garcia-Manero G, Santini V, et al. Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024;11(9)(suppl):e646-e658. doi:10.1016/52352-3026(24)00203-5 2. REBLOZYL [US Prescribing Information]. Summit. NJ: Celgene Corporation; 2026. 3. Park S, Grabar 5, Kelaidi C, et al. Predictive factors of response and survival in myelodysplastic syndrome treated with erythropoietin and G-CSF: the GFM experience. Blood. 2008;111(2):574-582. doi: 10.1182/blood-2007-06-096370 4. Data on file. BMS-REF-ACE-536-0009. Princeton, NJ: Bristol-Myers Squibb Company: 2023.

References

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.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 11.4% (63/554) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 2% to 9.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In ESA-refractory or -intolerant adult patients with MDS with normal baseline blood pressure, 26 (30%) patients developed SBP ≥130 mm Hg and 23 (16%) patients developed DBP ≥80 mm Hg. In ESA-naïve adult patients with MDS with normal baseline blood pressure, 23 (36%) patients developed SBP ≥140 mm Hg and 11 (6%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Extramedullary Hematopoietic (EMH) Masses

In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study).

In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta-Thalassemia

Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

ESA-naïve adult patients with Myelodysplastic Syndromes

Grade >3 (>2%) adverse reactions included hypertension and dyspnea.

The most common (>10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.

ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes

Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients.

The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

DRUG ABUSE POTENTIAL

Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.

For more information, please see US Full Prescribing Information for REBLOZYL.

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