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Safety and efficacy of luspatercept in treating anemia associated with myelodysplastic syndrome with ring sideroblasts in Asian patients who require red blood cell transfusions: a phase II bridging study

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机构： [1]Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. [2]Kitasato University Hospital, Sagamihara, Japan. [3]State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China. [4]The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. [5]NTT Medical Center Tokyo, Shinagawa City, Japan. [6]Nanfang Hospital of Southern Medical University, Guangzhou, China. [7]West China Hospital, Sichuan University, Chengdu, China. [8]Matsuyama Red Cross Hospital, Matsuyama, Japan. [9]Peking Union Medical College Hospital, Beijing, China. [10]The First Affiliated Hospital of Nanchang University, Nanchang, China. [11]Kindai University Hospital, Osaka, Japan. [12]The First Affiliated Hospital of Soochow University, Suzhou, China. [13]Osaka Metropolitan University Hospital, Osaka, Japan. [14]Bristol Myers Squibb, Princeton, NJ, USA. [15]Bristol Myers Squibb, Shanghai, China. [16]Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, No. 288, Nanjing Road, Heping District, Tianjin, 300020, China. [17]Dokkyo Medical University, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan.

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关键词： acute myeloid leukemia anemia China Japan luspatercept myelodysplastic syndrome

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Patients with lower-risk myelodysplastic syndromes (MDS) may experience anemia and a high transfusion burden, alongside a risk of progression to acute myeloid leukemia. Luspatercept, a recombinant fusion protein that acts as an erythroid maturation agent, was FDA/EMA-approved in 2020 based on the phase III MEDALIST trial. There remains an unmet need for anemia treatment in Asian patients for whom red blood cell (RBC) transfusion is a standard of care, and in whom rates/severity of anemia and serum erythropoietin levels are often higher versus Western patients.The objective of this study was to assess the efficacy, safety, and tolerability of luspatercept in Asian patients with anemia due to transfusion-dependent lower-risk MDS with ring sideroblasts.This was a phase II, single-arm, interventional bridging study (NCT04477850).Patients from China and Japan with very low-, low-, or intermediate-risk MDS with ring sideroblasts who were RBC transfusion-dependent received subcutaneous luspatercept starting at 1.0 mg/kg every 3 weeks. The primary endpoint was RBC transfusion independence (TI) ⩾8 weeks (weeks 1-24).There was a statistically significant, clinically meaningful improvement of anemia in Asian patients; 60% (n = 18, p < 0.0001) achieved RBC-TI for ⩾8 weeks and 43% (n = 13) for ⩾12 weeks (weeks 1-24). Safety was consistent with the known profile of luspatercept in MDS.These results support luspatercept as a well-tolerated, efficacious alternative to transfusions for Asian patients with lower-risk MDS, who tend to have more severe anemia. Trial registration: clinicaltrials.gov, NCT04477850.© The Author(s), 2025.

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大类 | 3 区医学

小类 | 3 区血液学

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大类 | 3 区医学

小类 | 3 区血液学

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无

最新[2023]版：

Q2 HEMATOLOGY

影响因子： 3.4 最新[2023版] 3.5 最新五年平均 0 出版当年[2024版] 0 出版当年五年平均 0 出版前一年[2024版]

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第一作者机构： [1]Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.

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