ELEMENT-MDS: This study is comparing the safety and effectiveness of two drugs in the treatment of anaemia in adults due to IPSS-R very low, low, intermediate-risk myelodysplastic syndromess (MDS) in ESA-naïve participants who are non-transfusion dependentA Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD)

Inclusion

• Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and: i) < 5% blasts in bone marrow and < 1% blasts in peripheral blood.
• Participant is not transfusion dependent (NTD) based on IWG2018 criteria
• Participant has never received treatment with an erythropoiesis stimulating agent (ESA)
• Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
• Participant has symptoms of anemia: i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
• Participant has a mean baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. Mean Hb is defined as the mean of all central/ local/ pretransfusion available Hb measurements during the 16 weeks prior to randomization (with a minimum of 2 measurements at least 1 week apart). Only Hb levels > 21 days following a transfusion are acceptable. The last measurement must be within 35 days of randomization.