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Xenopax for the treatment of steroid-refractory acute graft-versus-host disease: the RELAX study

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机构： [1]Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University, Beijing, 100044, China. [2]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, 300020, China. [3]Department of Hematology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, 450008, China. [4]Children's Hospital, Zhejiang University School of Medicine and National Clinical Research Center for Child Health, Hangzhou, 310052, China. [5]Department of Hematology, Henan Provincial People's Hospital, Zhengzhou, 450003, China. [6]Department of Hematology, Tianjin First Central Hospital, Tianjin, 300192, China. [7]Department of Hematology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430016, China. [8]Department of Hematology, People's Hospital of Zhengzhou, Zhengzhou, 450003, China. [9]Department of Hematology, Sichuan Provincial People's Hospital, Affiliated Hospital of University of Electronic Science and Technology of China, Chengdu, 610072, China. [10]Department of Hematology, Huai'an Second People's Hospital, Huai'an, 223002, Jiangsu, China. [11]Department of Hematology, the Third People's Hospital of Zhengzhou, Zhengzhou, 450003, China. [12]Department of Hematology, the Affiliated Tai'an City Central Hospital of Qingdao University, Tai'an, 271000, Shandong, China. [13]Anhui Public Health Clinical Center, the First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China. [14]The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China. [15]Department of Hematology, the Second Xiangya Hospital, Central South University, Changsha, 410011, China. [16]Department of Hematology, Affiliated Hospital of Jining Medical University, Jining, 272067, Shandong, China. [17]Department of Hematology, Affiliated Hospital of Nantong University, Nantong, 226001, Jiangsu, China. [18]Peking-Tsinghua Center for Life Sciences, Academy for Advanced Interdisciplinary Studies, Peking University, Beijing, 100871, China. [19]Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University, Beijing, 100044, China. moxiaodong@pkuph.edu.cn.

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关键词： Xenopax Acute graft-versus-host disease (aGVHD) Steroid refractory (SR) Allogeneic hematopoietic stem cell transplantation (allo-HSCT)

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Steroid-refractory (SR) acute graft-versus-host disease (aGVHD) is the major cause of early mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Xenopax, a novel and the only available humanized interleukin-2 (IL-2) receptor antagonist, has been approved as a category 2 biological product by the National Medical Products Administration. This study aims to evaluate the efficacy, safety, and prognostic factors of xenopax treatment for SR-aGVHD in real-world settings.This was a multicenter, retrospective analysis that included SR-aGVHD patients who received xenopax at 17 hospitals across China. The data were collected from the electronic medical records in transplant databases. The primary endpoint was the 28-day overall response rate (ORR), encompassing both partial and complete responses. This study also included independent historical SR-aGVHD cohorts treated with best available treatments (BATs, n = 1009) as controls.In total, 172 SR-aGVHD patients were included in this study. Xenopax was administered either as monotherapy (n = 60) or in combination with other second-line treatments (n = 112). The ORR was 64.5% [95% confidence interval (CI) 57.3-71.7%] on day 28 and 82.6% (95% CI 76.9-88.3%) at any time after xenopax treatment. The 2-year probabilities of disease-free survival, overall survival, non-relapse mortality (NRM), and relapse after xenopax treatment were 57.0% (95% CI 49.9-65.0%), 68.0% (95% CI 61.4-75.4%), 24.2% (95% CI 18.0-30.9%), and 19.0% (95% CI 12.8-25.2%), respectively. The ORR and survival were similar between patients with and without prior second-line treatments. The conditioning regimen and human leukocyte antigen disparity did not impact the efficacy of xenopax treatment. According to the multivariate analysis, the presence of grade III-IV aGVHD did not adversely affect the therapeutic response or survival. Xenopax also showed some superiority over BATs in historical cohorts.Our real-world findings suggest that xenopax is an effective and safe treatment for SR-aGVHD.© 2025. The Author(s).

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出版当年[2025]版：

大类 | 1 区

医学

小类 | 1 区医学：内科

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大类 | 1 区

医学

小类 | 1 区医学：内科

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出版当年[2024]版：

Q1 MEDICINE, GENERAL & INTERNAL

最新[2024]版：

Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 22.9 最新[2024版] 18.5 最新五年平均 22.9 出版当年[2024版] 0 出版当年五年平均 22.9 出版前一年[2024版]

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第一作者机构： [1]Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Cell and Gene Therapy for Hematologic Malignancies, Peking University, Beijing, 100044, China.

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Xenopax for the treatment of steroid-refractory acute graft-versus-host disease: the RELAX study

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