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Efficacy and safety of befotertinib (D-0316) in patients with EGFR T790M mutated non-small cell lung cancer that had progressed after prior EGFR TKI therapy: A phase 2, multicenter, single-arm, open-label study.

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作者：
Lu Shun[1,*1] * ; Zhang Yiping[2] ; Zhang Guojun[3] ; Zhou Jianying[4] ; Cang Shundong[5] ; Cheng Ying[6] ; Wu Gang[7] ; Cao Peiguo[8] ; Lv Dongqing[9] ; Jian Hong[10] ; Chen Chengshui[11] ; Jin Xiangming[12] ; Tian Panwen[13] ; Wang Kai[14] ; Jiang Guanming[15] ; Chen Gongyan[16] ; Chen Qun[17] ; Zhao Hui[18] ; Ding Cuimin[19] ; Guo Renhua[20] ; Sun Guoping[21] ; Wang Bin[22] ; Jiang Liyan[23] ; Liu Zhe[24] ; Fang Jian[25] ; Yang Junquan[26] ; Zhuang Wu[27] ; Liu Yunpeng[28] ; Zhang Jian[29] ; Pan Yueyin[30] ; Chen Jun[31] ; Yu Qitao[32] ; Zhao Min[33] ; Cui Jiuwei[34] ; Li Dianming[35] ; Yi Tienan[36] ; Yu Zhuang[37] ; Yang Yan[38] ; Zhang Yan[39] ; Zhi Xiuyi[40] ; Huang Yunchao[41] ; Wu Rong[42] ; Chen Liangan[43] ; Zang Aimin[44] ; Cao Lejie[45] ; Li Qingshan[46] ; Li Xiaoling[47] ; Song Yong[48] ; Wang Donglin[49] ; Zhang Shucai[24] ; Ding Lieming[50] ; Zhang Ling[51] ; Yuan Xiaobin[50] ; Yao Lin[50] ; Shen Zhilin[50] ;
机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. Electronic address: shunlu@sjtu.edu.cn. [2]Medical Department of Thoracic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China. [3]Department of Respiratory Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [4]Department of Respiratory Medicine, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China. [5]Department of Medical Oncology, Henan Provincial People's Hospital, Zhengzhou, China. [6]Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China. [7]Cancer center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. [8]Department of Oncology, The Third Xiangya Hospital of Central South University, Changsha, China. [9]Department of Respiratory Medicine, Taizhou hospital of Zhejiang Province, Linhai, China. [10]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. [11]Department of Respiratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. [12]Department of Medical Oncology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia. [13]Department of Respiratory and Critical Care Medicine, West China School of Medicine/West China Hospital of Sichuan University, Chengdu, China. [14]Department of Respiratory Medicine, The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, China. [15]Department of Medical Oncology, Dongguan People's Hospital, Dongguan, China. [16]Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, China. [17]Department of Oncology, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, China. [18]Department of Respiratory and Critical Care Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, China. [19]Department of Respiratory Medicine, The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital, Shijiazhuang, China. [20]Department of Oncology, The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China. [21]Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. [22]Department of Respiratory Medicine, Huzhou Central Hospital, Huzhou, China. [23]Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. [24]Department of Oncology, Beijing Chest Hospital, Capital Medical University, Beijing, China. [25]Department of Thoracic Oncology, Peking University Cancer Hospital, Beijing Cancer Hospital, Beijing, China. [26]Department of Radiotherapy and Chemotherapy, Tangshan People's Hospital, Tangshan, China. [27]Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China. [28]Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China. [29]Department of Respiratory Medicine, Air Force Medical University of PLA, the Fourth Military Medical University, Xi'an, China. [30]Department of Medical Oncology/Chemotherapy, The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Hospital, Hefei, China. [31]Department of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, China. [32]Department of Respiratory Oncology, The Guangxi Medical University Cancer Hospital, Guangxi Cancer Hospital, Nanning, China. [33]Department of Oncology, Hebei Chest Hospital, Shijiazhuang, China. [34]Cancer center, The First Hospital of Jilin University, Changchun, China. [35]Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China. [36]Department of Oncology, Xiangyang Central Hospital, Xiangyang, China. [37]Department of Medical Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China. [38]Department of Oncology, Chifeng Municipal Hospital, Chifeng, China. [39]Department of Oncology, Shijiazhuang People's Hospital, Shijiazhuang, China. [40]Department of Thoracic Surgery, Xuanwu Hospital Affiliated to Capital Medical University, Beijing, China. [41]Department of Thoracic Surgery, Yunnan Cancer Hospital /the Third Affiliated Hospital of Kunming Medical University, Kunming, China. [42]Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China. [43]Department of Respiratory Medicine, The first Medical Centre of Chinese PLA General Hospital, Beijing, China. [44]Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China. [45]Department of Respiratory Medicine, The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Hospital, Hefei, China. [46]Department of Medical Oncology, Affiliated Hospital of Chengde Medical College, Chengde, China. [47]Department of Thoracic Cancer, Liaoning Cancer Hospital & Institute, Shenyang, China. [48]Department of Respiratory Medicine, Jinling Hospital Nanjing University School of Medicine, Nanjing, China. [49]Department of Medical Oncology, Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing, China. [50]Betta Pharmaceuticals Co., Ltd, Hangzhou, China. [51]InventisBio Co., Ltd, Shanghai, China.
出处：
DOI： 10.1016/j.jtho.2022.06.002
ISSN：

关键词： Befotertinib EGFR NSCLC T790M Efficacy

摘要：
Befotertinib (D-0316) is a novel, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This study evaluated befotertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who developed an EGFR T790M mutation after progression on first- or second-generation EGFR TKI therapy.This was a single-arm, open-label, phase 2 study at 49 hospitals across mainland China. Patients with locally advanced or metastatic NSCLC harboring EGFR T790M mutations with disease progression following prior first- or second- generation EGFR TKI therapy received oral befotertinib of 50 mg (cohort A) or 75-100 mg (cohort B) once daily. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC) in intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT03861156.A total of 176 patients and 290 patients were included in cohorts A (50 mg) and B (75-100 mg), respectively. At data-cutoff (August 15, 2021), IRC-assessed ORR was 67.6% (95% confidence interval [CI]: 61.9%-72.9%) in cohort B. The investigator-assessed ORR was 54.0% (95% CI: 46.3%-61.5%) in cohort A and 65.9% (95% CI: 60.1%-71.3%) in cohort B. Investigator-assessed disease control rate was 93.2% (95% CI: 88.4%-96.4%) in cohort A and 94.8% (95% CI: 91.6%-97.1%) in cohort B. Investigator-assessed intracranial ORR was 26.7% (95% CI: 7.8%-55.1%) in cohort A and 57.1% (95% CI: 34.0%-78.2%) in cohort B. The median investigator-assessed progression-free survival (PFS) was 11.0 (95% CI: 9.6-12.5) months in cohort A and 12.5 (95% CI: 11.1-13.8) months in cohort B. The median investigator-assessed intracranial PFS was 16.5 (95% CI: 8.6-not evaluable [NE]) months in cohort A and NE (95% CI: 13.8-NE) in cohort B. The overall survival was immature. Grade 3 or higher treatment-related adverse events and treatment-related serious adverse events occurred in 20.5% and 11.4% of patients in cohort A, and in 29.3% and 10.0% of patients in cohort B, respectively.Befotertinib of 75-100 mg has satisfying efficacy and manageable toxicity in patients with locally advanced or metastatic NSCLC harboring T790M mutation with resistance to first- or second- generation EGFR TKIs. A phase 3 randomized trial is underway (NCT04206072).Copyright © 2022 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

基金：
This study was funded by Betta Pharmaceuticals and was also supported by National Key R&D Program of China (grant numbers 2016YFC1303300), the National Natural Science Foundation of China (82030045), Shanghai Municipal Science & Technology Commission Research Project (17431906103 and 19411950500).
语种：
外文
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出版当年[2022]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]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. Electronic address: shunlu@sjtu.edu.cn. [*1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China
通讯作者：
通讯机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. Electronic address: shunlu@sjtu.edu.cn. [*1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China
推荐引用方式(GB/T 7714)：
Lu Shun,Zhang Yiping,Zhang Guojun,et al.Efficacy and safety of befotertinib (D-0316) in patients with EGFR T790M mutated non-small cell lung cancer that had progressed after prior EGFR TKI therapy: A phase 2, multicenter, single-arm, open-label study.[J].Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.2022,doi:10.1016/j.jtho.2022.06.002.
APA：
Lu Shun,Zhang Yiping,Zhang Guojun,Zhou Jianying,Cang Shundong...&Shen Zhilin.(2022).Efficacy and safety of befotertinib (D-0316) in patients with EGFR T790M mutated non-small cell lung cancer that had progressed after prior EGFR TKI therapy: A phase 2, multicenter, single-arm, open-label study..Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,,
MLA：
Lu Shun,et al."Efficacy and safety of befotertinib (D-0316) in patients with EGFR T790M mutated non-small cell lung cancer that had progressed after prior EGFR TKI therapy: A phase 2, multicenter, single-arm, open-label study.".Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer .(2022)

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