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A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer

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资源类型：
Pubmed体系：
作者：
Li Ning[1] * ; Qiu Meng[2] ; Zhang Yanqiao[3] ; Yang Mudan[4] ; Lu Linzhi[5] ; Li Wei[6] ; Ma Yuntao[7] ; Hou Xiaoming[8] ; Sun Guoping[9] ; Cai Mingquan[10] ; Wang Jingran[11] ; Lu Jianwei[12] ; Zhong Diansheng[13] ; Huo Zhibin[14] ; Zhang Jingdong[15] ; Yin Xianli[16] ; Deng Jun[17] ; Liu Zimin[18] ; Pan Hongming[19] ; Chen Ye[20] ; Yang Futang[21] ; Yu Haoyu[21] ; Li Jing[21] ; Wang Qingyu[21] ; Zhu Jun[21] ; Li Jin[22] ;
机构： [1]Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou 450003,China [2]Department of Abdominal Oncology, West China Hospital, West China School of Medicine, Sichuan University, Chengdu 610041, China [3]Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China [4]Department of Gastroenterology, Shanxi Cancer Hospital, Taiyuan 030013, China [5]Department of Gastroenterology, Gansu Wuwei Tumour Hospital, Wuwei 733099, China [6]Cancer Center, The First Hospital of Jilin University, Changchun 130021, China [7]Department of General Surgery, Gansu Provincial Hospital, Lanzhou 730000, China [8]Department of Medical Oncology, The First Hospital of Lanzhou University, Lanzhou 730013, China [9]Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China [10]Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen 361001, China [11]Department of Oncology, Shijiazhuang People’s Hospital, Shijiazhuang 050030, China [12]Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of NanjingMedical University, Nanjing 210009, China [13]Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300041, China [14]Department of Gastrointestinal Surgical Oncology, Xingtai People’s Hospital, Xingtai 054001, China [15]Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute, Cancer Hospital of China [M]edicalUniversity, Shenyang 110042, China [16]Department of Gastroenterology and Urology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University, Changsha 410013, China [17]Department of Medical Oncology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang 330006, China [18]Department of Gastrointestinal Oncology, The Affiliated Hospital of Qingdao University, Qingdao 266031, China [19]Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China [20]Department of Gastrointestinal Surgical Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang471003, China [21]Shanghai Henlius Biotech, Inc., Shanghai 200233, China [22]Department of Medical Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China
出处：
DOI： 10.1016/j.medj.2024.06.004
ISSN：

摘要：
Gastric cancer is the fifth most common cancer and the fourth most common cause of cancer death worldwide, yet the prognosis of advanced disease remains poor.This was a randomized, double-blinded, phase 2 trial (ClinicalTrials.gov: NCT04908813). Patients with locally advanced/metastatic HER2-positive gastric/gastroesophageal junction cancer and no prior systemic antitumor therapy were randomized 1:1:1 to 25 mg/kg HLX22 (a novel anti-HER2 antibody) + HLX02 (trastuzumab biosimilar) + oxaliplatin and capecitabine (XELOX) (group A), 15 mg/kg HLX22 + HLX02 + XELOX (group B), or placebo + HLX02 + XELOX (group C) in 3-week cycles. Primary endpoints were progression-free survival (PFS) and objective response rate (ORR) assessed by independent radiological review committee (IRRC).Between November 29, 2021, and June 6, 2022, 82 patients were screened; 53 were randomized to group A (n = 18), B (n = 17), and C (n = 18). With 14.3 months of median follow-up, IRRC-assessed median PFS was prolonged with the addition of HLX22 (A vs. C, 15.1 vs. 8.2 months, hazard ratio [HR] 0.5 [95% confidence interval (CI) 0.17-1.27]; B vs. C, not reached vs. 8.2 months, HR 0.1 [95% CI 0.04-0.52]). Confirmed ORR was comparable among groups (A vs. B vs. C, 77.8% vs. 82.4% vs. 88.9%). Treatment-related adverse events (TRAEs) were observed in 18 (100%), 16 (94.1%), and 17 (94.4%) patients, respectively. One (5.6%) patient in group C reported a grade 5 TRAE.Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety.Shanghai Henlius Biotech, Inc.Copyright © 2024 Elsevier Inc. All rights reserved.

基金：
Shanghai Henlius Biotech, Inc
语种：
外文
PubmedID：
第一作者：
第一作者机构： [1]Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou 450003,China
通讯作者：
推荐引用方式(GB/T 7714)：
Li Ning,Qiu Meng,Zhang Yanqiao,et al.A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer[J].Med (New York, N.Y.).2024,doi:10.1016/j.medj.2024.06.004.
APA：
Li Ning,Qiu Meng,Zhang Yanqiao,Yang Mudan,Lu Linzhi...&Li Jin.(2024).A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer.Med (New York, N.Y.),,
MLA：
Li Ning,et al."A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer".Med (New York, N.Y.) .(2024)

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