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Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study

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Pubmed体系：
作者：
Li Ziming[1] * ; Wang Yan[2] ; Sun Yuping[3] ; Wang Linlin[4] ; Li Xingya[5] ; Sun Longhua[6] ; He Zhiyi[7] ; Yang Haiyan[8] ; Wang Yongsheng[9] ; Wang Qiming[10] ; Song Zhengbo[11] ; Hong Wei[12] ; Wang Yong[13] ; Xia Guohao[14] ; Yu Yan[15] ; Peng Min[16] ; Song Yong[17] ; Wang Donglin[18] ; Meng Rui[19] ; Fang Jian[20] ; Luo Yongzhong[21] ; Liang Wenhua[22] ; Hu Sheng[23] ; Wang Zhihui[24] ; Song Ke[25] ; Li You[25] ; Yang Lulu[25] ; Shi Wei[25] ; Lu Shun[26] ;
机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [2]Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China. [3]Phase I Clinical Research Center, The Affiliated Cancer Hospital of Shandong First Medical University, Jinan, China. [4]Chest Radiotherapy Third Ward, The Affiliated Cancer Hospital of Shandong First Medical University, Jinan, China. [5]Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [6]Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China. [7]Pulmonary and Critical Care Medicine Ward, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. [8]Department of Lung &amp Gastrointestinal Oncology, Hunan Cancer Hospital &amp The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. [9]Division of Thoracic Tumor Multimodality Treatment Cancer Center, West China Hospital, Sichuan University, Chengdu, China. [10]Department of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University-Henan Cancer Hospital &amp Institute of Cancer Research, Henan Academy of Innovations in Medical Science, Zhengzhou, China. [11]Phase I Clinical Trial Ward, Zhejiang Cancer Hospital, Hangzhou, China. [12]Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [13]Department of Medical Oncology, Anhui Provincial Hospital-The First Affiliated Hospital of the University of Science and Technology of China, Hefei, China. [14]Department of Medical Oncology, Jiangsu Cancer Hospital-Jiangsu Institute of Cancer Research-The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. [15]Department of Thoracic Medicine, Harbin Medical University Cancer Hospital, Harbin, China. [16]Department of Oncology, Renmin Hospital of Wuhan University, Wuhan, China. [17]Department of Respiratory Medicine, Jinling Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, China. [18]Department of Medical Oncology, Chongqing University Cancer Hospital, Chongqing, China. [19]Oncology Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [20]Department of Thoracic Oncology, Peking University Cancer Hospital, Beijing, China. [21]Department of Thoracic Medicine, Hunan Cancer Hospital &amp The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. [22]Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [23]Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, China. [24]Department of Thoracic Oncology, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. [25]Jiangsu Hengrui Pharmaceuticals, Shanghai, China. [26]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
出处：
DOI： 10.1016/S1470-2045(25)00012-9
ISSN：

摘要：
Trastuzumab rezetecan (also known as SHR-A1811) is a novel antibody-drug conjugate consisting of a humanised HER2-directed monoclonal antibody, cleavable tetrapeptide-based linker, and DNA topoisomerase I inhibitor. In the phase 1 portion of this phase 1/2 study, trastuzumab rezetecan showed preliminary anti-tumour activity and a favourable safety profile in patients with HER2-mutant non-small-cell lung cancer (NSCLC). We present phase 2 results from the study, which aimed to further evaluate the activity and safety of trastuzumab rezetecan at the recommended dose.In this multicentre, single-arm, phase 2 trial, conducted in 35 hospitals in China, we recruited patients aged 18-75 years, with locally advanced or metastatic NSCLC with an activating HER2 mutation and an Eastern Cooperative Oncology Group performance status score of 0-1, who had disease progression after or were intolerant to platinum-based chemotherapy and anti-PD-1 treatment or anti-PD-L1 treatment. Trastuzumab rezetecan was administered at 4·8 mg/kg intravenously once every 3 weeks. The primary endpoint was objective response rate assessed by an independent review committee in patients who received at least one cycle of study treatment. All patients who received at least one cycle of study treatment were included in safety analyses. This study is registered with ClinicalTrials.gov, NCT04818333, and is ongoing but not recruiting.Between April 14, 2023, and Dec 14, 2023, 94 patients were enrolled and treated. 42 (45%) patients were male, 52 (55%) female, 92 (98%) were Han Chinese, and two (2%) were other ethnicity Chinese. At data cutoff (June 14, 2024), the median duration of follow-up was 8·7 months (IQR 7·0-10·4). 69 (73%; 95% CI 63·3-82·0) of 94 patients had a confirmed objective response, as assessed by independent review committee. The most common grade 3-4 treatment-related adverse events were decreased neutrophil count (38 [40%] patients), decreased white blood cell count (25 [27%]), anaemia (22 [23%]), decreased platelet count (10 [11%]), and decreased lymphocyte count (seven [7%]). Treatment-related serious adverse events occurred in 22 (23%) patients, which were decreased platelet count (six [6%]), decreased neutrophil count (six [6%]), interstitial lung disease (five [5%]), decreased white blood cell count (four [4%]), anaemia (four [4%]), vomiting (three [3%]), pneumonia (three [3%]), hyponatraemia (two [2%]), and pyrexia (one [1%]), small intestinal obstruction (one [1%]), nausea (one [1%]), and chronic obstructive pulmonary disease (one [1%]). There were no treatment-related deaths.Trastuzumab rezetecan showed clinically meaningful activity and manageable safety in patients with previously treated HER2-mutant NSCLC. Further trials are justified.Jiangsu Hengrui Pharmaceuticals, National Multi-disciplinary Treatment Project for Major Diseases, Collaborative Innovation Center for Clinical and Translational Science by the Ministry of Education & Shanghai.For the Chinese translation of the abstract see Supplementary Materials section.Copyright © 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

基金：
Jiangsu Hengrui Pharmaceuticals, National Multi-disciplinary Treatment Project for Major Diseases, Collaborative Innovation Center for Clinical and Translational Science by the Ministry of Education & Shanghai.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
第一作者：
第一作者机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Li Ziming,Wang Yan,Sun Yuping,et al.Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study[J].The Lancet. Oncology.2025,doi:10.1016/S1470-2045(25)00012-9.
APA：
Li Ziming,Wang Yan,Sun Yuping,Wang Linlin,Li Xingya...&Lu Shun.(2025).Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study.The Lancet. Oncology,,
MLA：
Li Ziming,et al."Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study".The Lancet. Oncology .(2025)

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