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Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study

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作者：
Lu Shun[1,*1] ; Zhou Jianying[2,*2] ; Jian Hong[3] ; Wu Lin[4] ; Cheng Ying[5] ; Fan Yun[6] ; Fang Jian[7] ; Chen Gongyan[8] ; Zhang Zhihong[9] ; Lv Dongqing[10] ; Jiang Liyan[11] ; Wu Rong[12] ; Jin Xiangming[13] ; Zhang Xiaodong[14] ; Zhang Junhong[15] ; Xie Conghua[15] ; Sun Gengyun[16] ; Huang Dongning[17] ; Cui Jiuwei[18] ; Guo Renhua[19] ; Han Zhigang[20] ; Chen Zhendong[21] ; Liang Jin[22] ; Zhuang Wu[23] ; Hu Xingsheng[24] ; Zang Aimin[25] ; Zhang Yi[26] ; Cang Shundong[27] ; Lan Yuanbo[28] ; Chen Xi[29] ; Liu Laiyu[30] ; Li Xingya[31] ; Chen Jun[32] ; Ma Rui[33] ; Guo Yanzhen[34] ; Sun Ping[35] ; Tian Panwen[36] ; Pan Yueyin[37] ; Liu Zhe[38] ; Cao Peiguo[39] ; Ding Lieming[40] ; Wang Yang[40] ; Yuan Xiaobin[40] ; Wu Pengxiang[40] ;
机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China [2]Department of Respiratory Medicine, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [3]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. [4]Department of Thoracic Medical Oncology II, Hunan Cancer Hospital (The Affiliated Cancer Hospital of Xiangya School of Medicine), Central South University, Changsha, China. [5]Department of Oncology, Jilin Cancer Hospital, Changchun, China. [6]Department of Thoracic Medical Oncology II, Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China. [7]Department of Thoracic Surgery, Beijing Cancer Hospital, Beijing, China. [8]Department of Respiratory Medical Oncology, Harbin Medical University Affiliated Cancer Hospital, Harbin, China. [9]Department of Respiratory Medicine, Anhui Provincial Cancer Hospital, Hefei, China. [10]Breath Internal Medicine, Taizhou Hospital of Zhejiang Province, Linhai, China. [11]Department of Respiratory Medicine, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. [12]Second Oncology Ward, Shengjing Hospital of China Medical University, Shenyang, China. [13]Department of Oncology, General Hospital of Ningxia Medical University, Yinchuan, China. [14]Department of Internal Medicine-Oncology, Nantong Tumor Hospital, Nantong, China. [15]Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China. [16]Department of Respiratory Medicine, First Affiliated Hospital of Anhui Medical University, Hefei, China. [17]Department of Medical Oncology, Liuzhou Workers' Hospital, Liuzhou, China. [18]Department of Oncology, First Hospital of Jilin University, Changchun, China. [19]Department of Oncology, Jiangsu Province Hospital (First Affiliated Hospital of Nanjing Medical University), Nanjing, China. [20]Department of Pulmonary Medicine, 3rd Affiliated Teaching Hospital of Xinjiang Medical University (Affiliated Cancer Hospital), Urumqi, China. [21]Department of Medical Oncology, Second Hospital of Anhui Medical University, Hefei, China. [22]Department of Medical Oncology, First Affiliated Hospital of Kunming Medical University, Kunming, China. [23]Department of Thoracic Medical Oncology, Fujian Cancer Hospital, Fuzhou, China. [24]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [25]Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China. [26]Department of Thoracic Surgery, Xuanwu Hospital Capital Medical University, Beijing, China. [27]Department of Medical Oncology, Henan Provincial People's Hospital, Zhengzhou, China. [28]Department of Pneumology and Critical Care Medicine Respiratory Division II, Affiliated Hospital of Zunyi Medical University, Zunyi, China. [29]Department of Oncology, 900th Hospital of the Joint Logistics Support Force, Fuzhou, China. [30]Department of Respiratory Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, China. [31]Department of Medical Oncology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [32]Department of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, China. [33]Medical Oncology Department of Thoracic Cancer, Liaoning Cancer Hospital & Institute, Shenyang, China. [34]Department of Medical Oncology, Henan University of Science and Technology First Affiliated Hospital, Luoyang, China. [35]Oncology Department Two, Qindao University Medical College Affiliated Yantai Yuhuangding Hospital, Yantai, China. [36]Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China. [37]Department of Medical Oncology, Anhui Provincial Hospital, Hefei, China. [38]Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing, China. [39]Department of Oncology, Third Xiangya Hospital, Central South University, Changsha, China. [40]Betta Pharmaceuticals, Hangzhou, China.
出处：
DOI： 10.1016/S2213-2600(23)00183-2
ISSN：

摘要：
Befotertinib (D-0316) is a novel, selective oral third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor. This phase 3 trial compared the efficacy and safety of befotertinib with icotinib as a first-line treatment for patients with EGFR mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC).This study was a multicentre, open-label, randomised, controlled phase 3 study at 39 hospitals in China. Eligible patients were 18 years of age or older, had histologically confirmed locally advanced or metastatic stage IIIB, IIIC, or IV unresectable NSCLC, and had confirmed exon 19 deletions or exon 21 Leu858Arg mutation. Patients were randomly assigned (1:1) via an interactive web response system to receive either oral befotertinib (75-100 mg once daily) or oral icotinib (125 mg three times per day) in 21-day cycles until disease progression or withdrawal criteria were met. Randomisation was stratified by type of EGFR mutation, CNS metastasis status, and gender, and participants, investigators, and data analysts were not masked to treatment allocation. The primary endpoint was independent review committee (IRC)-assessed progression-free survival in the full analysis set, which comprised all randomly assigned patients. All patients who received at least one dose of the study drug were included in safety analyses. This study was registered with ClinicalTrials.gov, NCT04206072, and the overall survival follow-up is still in progress.Between Dec 24, 2019, and Dec 18, 2020, 568 patients were screened, of whom 362 were randomly assigned to the befotertinib (n=182) or icotinib (n=180) group; all 362 patients were included in the full analysis set. Median follow-up was 20·7 months (IQR 10·2-23·5) in the befotertinib group and 19·4 months (10·3-23·5) in the icotinib group. Median IRC-assessed progression-free survival was 22·1 months (95% CI 17·9-not estimable) in the befotertinib group and 13·8 months (12·4-15·2) in the icotinib group (hazard ratio 0·49 [95% CI 0·36-0·68], p<0·0001). Grade 3 or higher treatment-related adverse events occurred in 55 (30%) of 182 patients in the befotertinib group and in 14 (8%) of 180 patients in the icotinib group. Treatment-related serious adverse events were reported in 37 (20%) patients in the befotertinib group and in five (3%) patients in the icotinib group. Two (1%) patients in the befotertinib group and one (1%) patient in the icotinib group died due to treatment-related adverse events.Befotertinib demonstrated superior efficacy compared with icotinib in first-line treatment for patients with EGFR mutation-positive NSCLC. Although serious adverse events were more common in the befotertinib than the icotinib arm, the safety profile of befotertinib was manageable overall.Betta Pharmaceuticals (China).For the Chinese translation of the abstract see Supplementary Materials section.Copyright © 2023 Elsevier Ltd. All rights reserved.

基金：
This research was supported by Betta Pharmaceuticals and partly supported by the Chinese Government through grants from the Key Special Program for Innovative Drugs (2018ZX09711002-011-028).
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大类 | 1 区 医学
小类 | 1 区 危重病医学 1 区 呼吸系统
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出版当年[2023]版：
Q1 CRITICAL CARE MEDICINE Q1 RESPIRATORY SYSTEM
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Q1 CRITICAL CARE MEDICINE Q1 RESPIRATORY SYSTEM

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China [*1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China [2]Department of Respiratory Medicine, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [*1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China [*2]Department of Respiratory Medicine, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310003, China
推荐引用方式(GB/T 7714)：
Lu Shun,Zhou Jianying,Jian Hong,et al.Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study[J].LANCET RESPIRATORY MEDICINE.2023,11(10):905-915.doi:10.1016/S2213-2600(23)00183-2.
APA：
Lu Shun,Zhou Jianying,Jian Hong,Wu Lin,Cheng Ying...&Wu Pengxiang.(2023).Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study.LANCET RESPIRATORY MEDICINE,11,(10)
MLA：
Lu Shun,et al."Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study".LANCET RESPIRATORY MEDICINE 11..10(2023):905-915

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