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Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial

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收录情况： ◇ SCIE

作者：
Lu, Shun[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[1] ; Jin, Xiangming[10] ; Chen, Chengshui[11] ; Tian, Panwen[12] ; Wang, Kai[13] ; Jiang, Guanming[14] ; Chen, Gongyan[15] ; Chen, Qun[16] ; Zhao, Hui[17] ; Ding, Cuimin[18,19] ; 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] ; Ji, Dong[50] ; Shen, Zhilin[50] ;
机构： [1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Canc Ctr, 241 West Huaihai Rd, Shanghai 200030, Peoples R China [2]Univ Chinese Acad Sci, Zhejiang Canc Hosp, Med Dept Thorac Oncol, Canc Hosp, Hangzhou, Peoples R China [3]Zhengzhou Univ, Affiliated Hosp 1, Dept Resp Med, Zhengzhou, Peoples R China [4]Zhejiang Univ, Affiliated Hosp 1, Coll Med, Dept Resp Med, Hangzhou, Peoples R China [5]Henan Prov Peoples Hosp, Dept Med Oncol, Zhengzhou, Peoples R China [6]Jilin Canc Hosp, Dept Thorac Oncol, Changchun, Peoples R China [7]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Canc Ctr, Wuhan, Peoples R China [8]Cent South Univ, Xiangya Hosp 3, Dept Oncol, Changsha, Peoples R China [9]Taizhou Hosp Zhejiang Prov, Dept Resp Med, Linhai, Peoples R China [10]Ningxia Med Univ, Gen Hosp, Dept Med Oncol, Yinchuan, Ningxia, Peoples R China [11]Wenzhou Med Univ, Affiliated Hosp 1, Dept Resp Med, Wenzhou, Peoples R China [12]Sichuan Univ, West China Hosp, West China Sch Med, Dept Resp & Crit Care Med, Chengdu, Peoples R China [13]Zhejiang Univ, Affiliated Hosp 2, Med Coll, Dept Resp Med, Hangzhou, Peoples R China [14]Dongguan Peoples Hosp, Dept Med Oncol, Dongguan, Peoples R China [15]Harbin Med Univ, Canc Hosp, Dept Resp Med, Harbin, Peoples R China [16]Fuzhou Pulm Hosp Fujian, Dept Oncol, Fuzhou, Peoples R China [17]Anhui Med Univ, Affiliated Hosp 2, Dept Resp & Crit Care Med, Hefei, Peoples R China [18]Hebei Med Univ, Hosp 4, Dept Resp Med, Shijiazhuang, Peoples R China [19]Hebei Canc Hosp, Shijiazhuang, Peoples R China [20]Nanjing Med Univ, Affiliated Hosp 1, Jiangsu Prov Hosp, Dept Oncol, Nanjing, Peoples R China [21]Anhui Med Univ, Affiliated Hosp 1, Dept Med Oncol, Hefei, Peoples R China [22]Huzhou Cent Hosp, Dept Resp Med, Huzhou, Peoples R China [23]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Dept Resp Med, Shanghai, Peoples R China [24]Capital Med Univ, Beijing Chest Hosp, Dept Oncol, Beijing, Peoples R China [25]Peking Univ Canc Hosp, Beijing Canc Hosp, Dept Thorac Oncol, Beijing, Peoples R China [26]Tangshan Peoples Hosp, Dept Radiotherapy & Chemotherapy, Tangshan, Peoples R China [27]Fujian Canc Hosp, Dept Thorac Oncol, Fuzhou, Peoples R China [28]China Med Univ, Hosp 1, Dept Med Oncol, Shenyang, Peoples R China [29]Fourth Mil Med Univ, Air Force Med Univ PLA, Dept Resp Med, Xian, Peoples R China [30]Univ Sci & Technol China, Affiliated Hosp 1, Anhui Prov Hosp, Dept Med Oncol Chemotherapy, Hefei, Peoples R China [31]Tianjin Med Univ, Gen Hosp, Dept Lung Canc Surg, Tianjin, Peoples R China [32]Guangxi Med Univ, Canc Hosp, Guangxi Canc Hosp, Dept Resp Oncol, Nanning, Peoples R China [33]Hebei Chest Hosp, Dept Oncol, Shijiazhuang, Peoples R China [34]First Hosp Jilin Univ, Canc Ctr, Changchun, Peoples R China [35]Bengbu Med Coll, Affiliated Hosp 1, Dept Resp & Crit Care Med, Bengbu, Peoples R China [36]Xiangyang Cent Hosp, Dept Oncol, Xiangyang, Peoples R China [37]Qingdao Univ, Affiliated Hosp, Dept Med Oncol, Qingdao, Peoples R China [38]Chifeng Municipal Hosp, Dept Oncol, Chifeng, Peoples R China [39]Shijiazhuang Peoples Hosp, Dept Oncol, Shijiazhuang, Peoples R China [40]Capital Med Univ, Xuanwu Hosp, Dept Thorac Surg, Beijing, Peoples R China [41]Kunming Med Univ, Yunnan Canc Hosp, Affiliated Hosp 3, Dept Thorac Surg, Kunming, Peoples R China [42]China Med Univ, Shengjing Hosp, Dept Oncol, Shenyang, Peoples R China [43]Chinese Peoples Liberat Army Gen Hosp, Med Ctr 1, Dept Resp Med, Beijing, Peoples R China [44]Hebei Univ, Affiliated Hosp, Dept Med Oncol, Baoding, Peoples R China [45]Univ Sci & Technol China, Affiliated Hosp 1, Anhui Prov Hosp, Dept Resp Med, Hefei, Peoples R China [46]Chengde Med Coll, Affiliated Hosp, Dept Med Oncol, Chengde, Peoples R China [47]Liaoning Canc Hosp & Inst, Dept Thorac Canc, Shenyang, Peoples R China [48]Nanjing Univ, Jinling Hosp, Sch Med, Dept Resp Med, Nanjing, Peoples R China [49]Chongqing Univ, Canc Hosp, Chongqing Canc Hosp, Dept Med Oncol, Chongqing, Peoples R China [50]Betta Pharmaceut Co Ltd, Hangzhou, Peoples R China [51]InventisBio Co Ltd, Shanghai, Peoples R China
出处：
DOI： 10.1016/j.lungcan.2024.107901
ISSN：

关键词： Befotertinib EGFR TKI NSCLC Overall survival

摘要：
Background: In the initial analysis of a pivotal phase 2 single-arm study (NCT03861156), befotertinib (D-0316) showed clinical benefit with a manageable safety profile in pretreated patients with EGFR T790M mutated non- small cell lung cancer (NSCLC), including those with brain metastases. Methods: Eligible patients received oral befotertinib of 50 mg (cohort A) or 75-100 mg (cohort B) once daily until disease progression, withdrawal of informed consent, or death. The primary endpoint for the initial analysis was objective response rate (ORR) assessed by an independent review committee. OS and safety were secondary endpoints. Herein, we present the final OS and safety data. Results: A total of 176 patients in cohort A and 290 patients in cohort B were finally enrolled. At data cutoff (May 31, 2023), the median duration of follow-up was 47.9 months (95% CI: 47.1-48.3) in cohort A and 36.7 months (35.9-37.9) in cohort B. The median OS was 23.9 months (95 % CI: 21.1-27.2) in cohort A and 31.5 months (26.8-35.3) in cohort B. The median OS for patients with and without brain metastasis in cohort A was 18.6 months (95 % CI: 14.9-26.3) and 26.4 months (95 % CI: 23.0-29.0), respectively. In cohort B, these data was 23.0 months (95 % CI: 18.6-29.1) and 35.5 months (95 % CI: 29.3-NE), respectively. The safety profile of befotertinib remained consistent with previous data. Grade 3 or higher treatment-emergent adverse events were 38.1 % in the cohort A and 50.3 % in the cohort B, and 22.2 % and 31.7 % were related to the study drug. Conclusion: Befotertinib demonstrated a more profound OS benefit compared to other 3rd-generation EGFR TKI, despite that cross trial data comparison should be interpreted with caution. The safety profile was manageable and consistent with previously report data in pretreated patients with confirmed T790M mutation-positive NSCLC.

基金：
Betta Pharmaceuticals Co., Ltd
语种：
外文
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
最新[2023]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
JCR分区：
出版当年[2023]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM
最新[2023]版：
Q1 ONCOLOGY 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[2023版]

第一作者：
第一作者机构： [1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Canc Ctr, 241 West Huaihai Rd, Shanghai 200030, Peoples R China
通讯作者：
推荐引用方式(GB/T 7714)：
Lu Shun,Zhang Yiping,Zhang Guojun,et al.Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial[J].LUNG CANCER.2024,195:doi:10.1016/j.lungcan.2024.107901.
APA：
Lu, Shun,Zhang, Yiping,Zhang, Guojun,Zhou, Jianying,Cang, Shundong...&Shen, Zhilin.(2024).Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial.LUNG CANCER,195,
MLA：
Lu, Shun,et al."Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial".LUNG CANCER 195.(2024)

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