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First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial

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资源类型：
Pubmed体系：
作者：
Wang Zi-Xian[1,2] ; Peng Junjie[3] ; Liang Xinjun[4] ; Cheng Ying[5] ; Deng Yanhong[6] ; Chen Kehe[7] ; Zhang Mingjun[8] ; Zhang Jingdong[9] ; Wang Wei[10] ; Cao Bangwei[11] ; Jin Yongdong[12] ; Sun Meili[13] ; Lin Yuan[14] ; Luo Suxia[15] ; Li Zhen[16] ; Yang Liu[17] ; Ke Ying[18] ; Yu Haoyu[18] ; Li Jing[18] ; Wang Qingyu[18] ; Zhu Jun[18] ; Wang Feng[1,2] ; Xu Rui-Hua[1,2] ;
机构： [1]1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China [2]Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China [3]Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China [4]Department of Abdominal Oncology, Hubei Cancer Hospital, Wuhan, China [5]Department of Medical Oncology, Jilin Cancer Hospital, Changchun, China [6]Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China [7]Department of Medical Oncology, The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, China [8]Department of Oncology, The Second Hospital of Anhui Medical University, Hefei, China [9]Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang, China [10]Department of Gastrointestinal Oncology, The First People’s Hospital of Foshan, Foshan, China [11]Department of Oncology, Beijing Friendship Hospital, Capital Medical University, Beijing, China [12]Department of Abdominal Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, China [13]Department of Oncology, Jinan Central Hospital, Central Hospital Affiliated to Shandong First Medical University, Jinan, China [14]Department of Gastrointestinal Surgery, Guangxi Medical University Cancer Hospital, Nanning, China [15]Department of Medical Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China [16]Department of Medical Oncology, Linyi Cancer Hospital, Linyi, China [17]Cancer Center, Department of Medical Oncology, Zhejiang Provincial People’s Hospital, People’s Hospital of Hangzhou Medical College, Hangzhou, China [18]Shanghai Henlius Biotech, Inc., Shanghai, China
出处：
DOI： 10.1016/j.medj.2024.05.009
ISSN：

摘要：
Whether or not the addition of immunotherapy to current standard-of-care treatments can improve efficacy in proficient mismatch repair (pMMR)/microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), the predominant type of mCRC, is unclear.This randomized, double-blind, phase 2 part of a phase 2/3 trial was conducted at 23 hospitals across China (ClinicalTrials.gov: NCT04547166). Patients with unresectable metastatic/recurrent colorectal adenocarcinoma and no prior systemic therapy were randomly assigned 1:1 to receive every-3-weeks intravenous serplulimab (300 mg) plus HLX04 (7.5 mg/kg) and XELOX (serplulimab group) or placebo (300 mg) plus bevacizumab (7.5 mg/kg) and XELOX (placebo group). The primary endpoint was independent radiology review committee (IRRC)-assessed progression-free survival (PFS). Secondary endpoints included other efficacy endpoints and safety.Between July 16, 2021, and January 20, 2022, 114 patients were enrolled and randomly assigned to the serplulimab (n = 57) or placebo (n = 57) group. All patients had stage IV CRC, and 95.7% of the patients with available microsatellite instability (MSI) status were MSS. With a median follow-up duration of 17.7 months, median PFS was prolonged in the serplulimab group (17.2 vs. 10.7 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.31-1.14). Although the median overall survival (OS) was not reached for either group, a trend of an OS benefit was observed for the serplulimab group (HR, 0.77; 95% CI, 0.41-1.45). 36 (65.5%) and 32 (56.1%) patients in the serplulimab and placebo groups had grade ≥3 treatment-related adverse events, respectively.Serplulimab plus HLX04 and XELOX exhibits promising efficacy and is safe and tolerable in patients with treatment-naive mCRC.This work was funded by Shanghai Henlius Biotech, Inc.Copyright © 2024 Elsevier Inc. All rights reserved.

基金：
This study was funded by Shanghai Henlius Biotech, Inc. This study was also supported by the Cancer Innovation Research Program of Sun Yat-sen University Cancer Center.
语种：
外文
PubmedID：
第一作者：
第一作者机构： [1]1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China [2]Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China
共同第一作者：
通讯作者：
通讯机构： [1]1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China [2]Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China
推荐引用方式(GB/T 7714)：
Wang Zi-Xian,Peng Junjie,Liang Xinjun,et al.First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial[J].Med (New York, N.Y.).2024,doi:10.1016/j.medj.2024.05.009.
APA：
Wang Zi-Xian,Peng Junjie,Liang Xinjun,Cheng Ying,Deng Yanhong...&Xu Rui-Hua.(2024).First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial.Med (New York, N.Y.),,
MLA：
Wang Zi-Xian,et al."First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial".Med (New York, N.Y.) .(2024)

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