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Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial.

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Pubmed体系：
作者：
Lu Shun[1,*1] ; Wang Qiming[2] ; Zhang Guojun[3] ; Dong Xiaorong[4] ; Yang Cheng-Ta[5] ; Song Yong[6] ; Chang Gee-Chen[7] ; Lu You[8] ; Pan Hongming[9] ; Chiu Chao-Hua[10] ; Wang Zhehai[11] ; Feng Jifeng[12] ; Zhou Jianying[13] ; Xu Xingxiang[14] ; Guo Renhua[15] ; Chen Jianhua[16] ; Yang Haihua[17] ; Chen Yuan[18] ; Yu Zhuang[19] ; Shiah Her-Shyong[20] ; Wang Chin-Chou[21] ; Yang Nong[22] ; Fang Jian[23] ; Wang Ping[24] ; Wang Kai[25] ; Hu Yanping[26] ; He Jianxing[27] ; Wang Ziping[23] ; Shi Jianhua[28] ; Chen Shaoshui[29] ; Wu Qiong[30] ; Sun Changan[31] ; Li Chuan[30] ; Wei Hongying[30] ; Cheng Ying[32] ; Su Wu-Chou[33] ; Hsia Te-Chun[34] ; Cui Jiuwei[35] ; Sun Yuping[36] ; Ou Sai-Hong Ignatius[37] ; Zhu Viola W[37] ; Chih-Hsin Yang James[38] ;
机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China. Electronic address: shunlu@sjtu.edu.cn. [2]Department of Internal Medicine, Henan Cancer Hospital Affiliated to Zhengzhou University, Zhengzhou, People's Republic of China. [3]Department of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China. [4]Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, People's Republic of China. [5]Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan. [6]Department of Respiration, General Hospital of The PLA Eastern Theater Command, Nanjing, People's Republic of China. [7]Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. [8]Department of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, People's Republic of China. [9]Department of Oncology, Sir Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China. [10]Division of Thoracic Oncology, Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. [11]Department of Oncology, Shandong Cancer Hospital, Jinan, People's Republic of China. [12]Department of Internal Medicine, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, People's Republic of China. [13]Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China. [14]Department of Respiration, Northern Jiangsu People's Hospital, The Affiliated Hospital to Yangzhou University, Yangzhou, People's Republic of China. [15]Department of Medical Oncology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China. [16]Department of Medical Oncology-Chest, Hunan Cancer Hospital &The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, People's Republic of China. [17]Department of Radiotherapy, Taizhou Hospital of Zhejiang Province, Taizhou, People's Republic of China. [18]Department of Oncology, Tongji Medical College Huazhong University of Science &Technology, Wuhan, People's Republic of China. [19]Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, People's Republic of China. [20]Graduate Institute of Cancer Biology and Drug Discovery, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan. [21]Department of Occupational Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. [22]Department of Pulmonary Gastroenterology, Hunan Cancer Hospital &The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, People's Republic of China. [23]Department of Chest Medicine, Beijing Cancer Hospital, Beijing, People's Republic of China. [24]Department of Radiotherapy, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People's Republic of China. [25]Department of Respiration, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, People's Republic of China. [26]Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, People's Republic of China. [27]Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China. [28]Department of Internal Medicine, Linyi Cancer Hospital, Linyi, People's Republic of China. [29]Department of Oncology, Binzhou Medical University Hospital, Binzhou, People's Republic of China. [30]Clinical Medical Group, Jiangsu Hansoh Pharmaceutical Group Co. Ltd., Shanghai, People's Republic of China. [31]Clinical Operation Group, Jiangsu Hansoh Pharmaceutical Group Co. Ltd., Shanghai, People's Republic of China. [32]Department of Internal Medicine, Jilin Cancer Hospital, Changchun, People's Republic of China. [33]Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Taipei, Taiwan. [34]Division of Pulmonary and Critical Care Medicine, China Medical University Hospital, Taichung, Taiwan. [35]Department of Oncology, The First Bethune Hospital of Jilin University, Changchun, People's Republic of China. [36]Department of Oncology, Jinan Central Hospital, Jinan, People's Republic of China. [37]Chao Family Comprehensive Cancer Center, Department of Medicine, Division of Hematology and Oncology, University of California, Irvine School of Medicine, Orange, California. [38]Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
出处：
DOI： 10.1016/j.jtho.2021.10.024
ISSN：

摘要：
Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation EGFR tyrosine kinase inhibitor (TKI) with revealed activity against EGFR-sensitizing mutations and EGFR T790M mutation.Patients with locally advanced or metastatic NSCLC who developed an EGFR T790M mutation after progression on first- or second-generation EGFR TKI therapy were enrolled in this registrational phase 2 trial of aumolertinib at 110 mg orally once daily (NCT02981108). The primary end point was objective response rate (ORR) by independent central review.A total of 244 patients with EGFR T790M-positive NSCLC were enrolled. The ORR by independent central review was 68.9% (95% confidence interval [CI]: 62.6-74.6). The disease control rate was 93.4% (95% CI: 89.6-96.2). The median duration of response was 15.1 months (95% CI: 12.5-16.6). The median progression-free survival was 12.4 months (95% CI: 9.7-15.0). Among 23 patients with assessable central nervous system (CNS) metastases, the CNS-ORR and CNS-disease control rate were 60.9% (95% CI: 38.5-80.3) and 91.3% (95% CI: 72.0-98.9), respectively. The median CNS-duration of response was 12.5 months (95% CI: 5.6-not reached). Treatment-related adverse events of more than or equal to grade 3 occurred in 16.4% of the patients, with the most common being increased blood creatine phosphokinase level (7%) and increased alanine aminotransferase level (1.2%). The relative dose density of aumolertinib was 99.2% in this study.Aumolertinib is an effective and well-tolerated third-generation EGFR TKI for patients with EGFR T790M-positive advanced NSCLC after disease progression on first- and second-generation EGFR TKI therapy. On the basis of these findings, aumolertinib was approved in the People's Republic of China for patients positive for EGFR T790M NSCLC.Copyright © 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

基金：
This work was supported by Hansoh Pharmaceutical Group Co., Ltd., The National Key R&D Program of China (2016YFC1303300), and the Shanghai Science and Technology Innovation Program (19411950500). The authors thank all patients and their families, along with the investigators and staffs at the participating centers. We also thank the study teams from Hansoh Pharmaceutical Group Co., Ltd., including Xiaoling Qian, Qiang Zhang, Wanyi Huang, Yong Yang, Xue Sun, and Qiu Sun, for their support, the Teddy Clinical Research Laboratory (Shanghai, People’s Republic of China) for EGFR mutation test, and the Fantastic Bioimaging (Shanghai, People’s Republic of China) for independent central review assessment.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
第一作者：
第一作者机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China. Electronic address: shunlu@sjtu.edu.cn. [*1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, People’s Republic of China.
通讯作者：
通讯机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China. Electronic address: shunlu@sjtu.edu.cn. [*1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, People’s Republic of China.
推荐引用方式(GB/T 7714)：
Lu Shun,Wang Qiming,Zhang Guojun,et al.Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial.[J].Journal Of Thoracic Oncology : Official Publication Of The International Association For The Study Of Lung Cancer.2021,doi:10.1016/j.jtho.2021.10.024.
APA：
Lu Shun,Wang Qiming,Zhang Guojun,Dong Xiaorong,Yang Cheng-Ta...&Chih-Hsin Yang James.(2021).Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial..Journal Of Thoracic Oncology : Official Publication Of The International Association For The Study Of Lung Cancer,,
MLA：
Lu Shun,et al."Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial.".Journal Of Thoracic Oncology : Official Publication Of The International Association For The Study Of Lung Cancer .(2021)

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