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Penpulimab for Relapsed or Refractory Classical Hodgkin Lymphoma: A Multicenter, Single-Arm, Pivotal Phase I/II Trial (AK105-201)

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机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, PekingUniversity Cancer Hospital & Institute, Beijing, China, [2]Department of Hematology, The Affiliated Cancer Hospital ofZhengzhou University and Henan Cancer Hospital, Zhengzhou, China, [3]Department of Oncology, Cancer Hospital Affiliatedto Guangzhou Medical University, Guangzhou, China, [4]Department of Lymphoma, Tianjin Medical University Cancer Instituteand Hospital, National Clinical Research Center of Cancer, Key Laboratory of Cancer Prevention and Therapy, the Sino-USCenter for Lymphoma and Leukemia Research, Tianjin, China, [5]Department of Hematology, Qilu Hospital, ShandongUniversity, Jinan, China.Shandong Provincial Key Laboratory of Immunohematology, Qilu Hospital, Shandong University,Jinan, China, [6]Department of Hematology, The First Affiliated Hospital with Nanjing Medical University, Jiangsu ProvinceHospital, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, China, [7]Department of Hematology,The First Affiliated Hospital of Nanchang University, Nanchang, China, [8]Department of Hematology, The First AffiliatedHospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China, [9]Lymphoma & Hematology Department, Tumor Hospital of Xiangya School of Medicine of Central South University,Changsha, China, [10]Department of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, China, [11]Department of Hematology, Nanjing Drum Tower Hospital, Clinical College of Nanjing Medical University, Nanjing, China, [12]Department of Medical Oncology, Second Affiliated Hospital of Dalian Medical University, Dalian, China, [13]Department ofHematology, Shanghai First People’s Hospital, Shanghai Jiaotong University, Shanghai, China, [14]Department of MedicalOncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China, [15]Department of Medical Oncology,Heilongjiang Provincial Hospital, Harbin, China, [16]Department of Hematology, The Fourth Hospital of Hebei MedicalUniversity, Shijiazhuang, China, [17]Clinical Oncology Department, Weifang People’s Hospital, Weifang, China, [18]Institute ofHematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, [19]Third Department of Medical Oncology, Shaanxi Provincial Cancer Hospital, Xi’an, China, [20]Department of Hematology,Shanghai Tongren Hospital, Shanghai, China, [21]Department of Hematology, The Affiliated Hospital of Qingdao University,Qingdao, China, [22]Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China, [23]Department of Hematology, The Third Affiliated Hospital of Suzhou University, The First People’s Hospital of Changzhou,Changzhou, China, [24]Akeso Biopharma Co., Ltd., Zhongshan, China
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Nearly all anti-PD-1 antibodies are of the IgG4 isotype, and thus possess residual FcR effector functions. Such anti-PD-1 antibodies are also associated with immune tolerance and escape due to instability of the CH3 domain and Fc-Fc interaction. In this trial, we examined the efficacy and safety of penpulimab, a novel IgG1 anti-PD-1 antibody that does not bind to the Fc receptor, in patients with refractory or relapsed classical Hodgkin lymphoma (R/R cHL).Adult patients (≥18 years of age) with R/R cHL received 200 mg penpulimab once biweekly until disease progression or unacceptable toxicities for a maximum of 24 months. The primary endpoint was objective response rate (ORR) based on the Independent Radiology Review Committee per Lugano 2014 criteria. Secondary endpoints included progression-free survival (PFS), overall survival (OS), treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs).A total of 94 patients were enrolled. The median follow-up was 15.8 months. The ORR was 89.4% (95% CI 80.8%, 95.0%) in the full analysis set (85 patients). Forty (47.1%) patients achieved complete remission, 36 (42.4%) patients achieved partial remission. The 12-month PFS rate was 72.1% (95% CI 60.5%, 80.8%) and the 18-month OS rate was 100%. Totally 97.9% (92/94) of patients experienced at least one TRAE. The rate of grade 3 and above TRAEs was 26.6% (25/94). In addition, 51 (54.3%) patients experienced an irAE, and 4 (4.3%) patients developed grade 3 or above irAEs. No irAE-related death occurred.Penpulimab was effective and safe in patients with R/R cHL.Copyright © 2022 Song, Zhou, Jin, Qian, Hou, Fan, Li, Ding, Zhou, Li, Chen, Sun, Song, Jiang, Zhang, Liu, Yu, Hu, Zhao, Liu, Xue, Luo, He, Jin, Zhao, Li, Xia and Zhu.

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大类 | 3 区 医学
小类 | 3 区 肿瘤学
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大类 | 3 区 医学
小类 | 3 区 肿瘤学
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Q2 ONCOLOGY
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Q2 ONCOLOGY

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第一作者机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, PekingUniversity Cancer Hospital & Institute, Beijing, China,
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