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oai:recercat.cat:11351/133982025-07-13T07:41:54Zcom_2072_378070com_2072_378040col_2072_378092

Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial Garcia-Manero, Guillermo SANTINI, VALERIA Zeidan, Amer Komrokji, Rami S. Pozharskaya, Veronika Rose, Shelonitda VALCARCEL, DAVID Institut Català de la Salut [Garcia-Manero G] MD Anderson Cancer Center, Houston, TX, USA. [Santini V] MDS Unit, DMSC, University of Florence, AOUC, Florence, Italy. [Zeidan AM] Yale School of Medicine, New Haven, CT, USA. [Komrokji RS] Moffitt Cancer Center, Tampa, FL, USA. [Pozharskaya V, Rose S] Bristol Myers Squibb, Princeton, NJ, USA. [Valcárcel D] Vall d’Hebron, Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain Vall d'Hebron Barcelona Hospital Campus Síndromes mielodisplàsiques - Tractament Anèmia - Tractament Sang - Transfusió Eritropoetina DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Bone Marrow Diseases::Myelodysplastic Syndromes Other subheadings::Other subheadings::/therapy DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines::Hematopoietic Cell Growth Factors::Colony-Stimulating Factors::Erythropoietin::Epoetin Alfa ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Blood Transfusion ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Blood Transfusion::Blood Component Transfusion::Erythrocyte Transfusion ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::enfermedades de la médula ósea::síndromes mielodisplásicos Otros calificadores::Otros calificadores::/terapia ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::anemia COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::citocinas::factores de crecimiento de células hematopoyéticas::factores estimulantes de colonias::eritropoyetina::epoetina alfa TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::transfusión sanguínea TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::transfusión sanguínea::transfusión de componentes sanguíneos::transfusión de eritrocitos Epoetin alfa; Erythroid-stimulating agents; Myelodysplastic syndromes Epoetina alfa; Agentes estimulantes de eritroides; Síndromes mielodisplásicos Epoetina alfa; Agents estimulants d'eritroides; Síndromes mielodisplàsiques Introduction The efficacy of erythropoiesis-stimulating agents (ESAs) for transfusion-dependent (TD) anemia in lower-risk myelodysplastic syndromes (LR-MDS) is limited. Luspatercept achieved significantly greater rates of red blood cell (RBC) transfusion independence (TI) versus epoetin alfa (an ESA) in the phase 3 COMMANDS trial. This analysis assessed long-term RBC-TI, cumulative response, and safety with luspatercept in COMMANDS. Methods Eligible patients aged ≥ 18 years, with ESA-naive, RBC TD LR-MDS were randomized 1:1 to receive luspatercept (1.0 mg/kg, titration to 1.75 mg/kg permitted) or epoetin alfa (450 IU/kg, titration to 1050 IU/kg). Disease assessment was carried out at week 24 (day 169) and every 24 weeks thereafter. Treatment continued until disease progression, lack of clinical benefit, unacceptable toxicity, or consent withdrawal. Results At data cutoff (September 22, 2023; median follow-up: luspatercept 21.4 months, epoetin alfa 20.3 months), a greater proportion of patients treated with luspatercept (n = 182) versus epoetin alfa (n = 181) achieved a longest single RBC-TI period ≥ 1 year (44.5% vs. 27.6%; P = 0.0003) and ≥ 1.5 years (30.2% vs. 13.8%; P < 0.0001). Higher rates of RBC-TI ≥ 1.5 years with luspatercept over epoetin alfa were consistent across all prespecified subgroups, including patients with ring sideroblast-negative status and low baseline serum erythropoietin. Longer cumulative RBC-TI response [sum of all durations of RBC-TI for ≥ 12 weeks; week 1 to end of treatment (95% CI)] was observed with luspatercept [154.7 weeks (118.4–NR)] versus epoetin alfa [91.1 weeks (73.1–123.9)]. Rates of treatment-emergent adverse events, including asthenia and hypertension, generally decreased over time in both arms. Progression rates to high-risk MDS and acute myeloid leukemia were similarly low (< 5%) in both treatment arms. Conclusions These data demonstrated sustained, durable clinical benefit across subgroups and support luspatercept as the treatment of choice for anemia in patients with LR-MDS who are TD and ESA-naive. Trial Registration Number NCT03682536. The study was supported by Celgene, a Bristol-Myers Squibb Company, in collaboration with Acceleron Pharma Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Study drugs were provided by Bristol Myers Squibb (Princeton, NJ, USA). Rapid Service Fees for publication were funded by Bristol Myers Squibb (Princeton, NJ, USA). 2025-07-11T07:18:51Z 2025-07-11T07:18:51Z 2025-07 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Pozharskaya V, Rose S, et al. Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial. Adv Ther. 2025 Jul;42:3576–3589. 1865-8652 http://hdl.handle.net/11351/13398 10.1007/s12325-025-03208-5 40377899 001489760700001 http://hdl.handle.net/11351/13398 eng Advances in Therapy;42 https://doi.org/10.1007/s12325-025-03208-5 Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess application/pdf Adis Scientia