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Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer

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收录情况： ◇ SCIE ◇ 自然指数

作者：
Shen Zhao[1] * ; Wu Zhuang[2] * ; Baohui Han[3] * ; Zhengbo Song[4] * ; Wei Guo[5] * ; Feng Luo[6] * ; Lin Wu[7] ; Yi Hu[8] ; Huijuan Wang[9] ; Xiaorong Dong[10] ; Da Jiang[11] ; Mingxia Wang[12] ; Liyun Miao[13] ; Qian Wang[14] ; Junping Zhang[15] ; Zhenming Fu[16] ; Yihua Huang[1] ; Chunwei Xu[17] ; Longyu Hu[18] ; Lei Li[19] ; Rong Hu[19] ; Yang Yang[19] ; Mengke Li[19] ; Xiugao Yang[19] ; Li Zhang[1] ; Yan Huang[1] ; Wenfeng Fang[1] ;
机构： [1]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China. [2]Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China. [3]Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai, China. [4]Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [5]Department of Respiratory Medicine, Shanxi Provincial Cancer Hospital, Taiyuan, China. [6]Lung Cancer Center, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, China. [7]Department of Thoracic Medicine, Hunan Cancer Hospital, Changsha, China. [8]Department of Medical Oncology, Chinese PLA General Hospital, Beijing, China. [9]Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China. [10]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [11]Department of Medical Oncology, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, China. [12]Department of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, China. [13]Department of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China. [14]Department of Respiratory Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China. [15]Department of Medical Oncology, Shanxi Bethune Hospital, Taiyuan, China. [16]Cancer Center, Renmin Hospital of Wuhan University, Wuhan, China. [17]Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. [18]HaploX Biotechnology Co,. Ltd., Shenzhen, China. [19]Clinical Science Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
出处：
DOI： 10.1038/s41467-023-39139-4
ISSN：

摘要：
EGFR exon 20 insertion (20ins)-positive non-small-cell lung cancer (NSCLC) is an uncommon disease with limited therapeutic options and dismal prognosis. Here we report the activity, tolerability, potential mechanisms of response and resistance for dual targeting EGFR 20ins with JMT101 (anti-EGFR monoclonal antibody) plus osimertinib from preclinical models and an open label, multi-center phase 1b trial (NCT04448379). Primary endpoint of the trial is tolerability. Secondary endpoints include objective response rate, duration of response, disease control rate, progression free survival, overall survival, the pharmacokinetic profile of JMT101, occurrence of anti-drug antibodies and correlation between biomarkers and clinical outcomes. A total of 121 patients are enrolled to receive JMT101 plus osimertinib 160 mg. The most common adverse events are rash (76.9%) and diarrhea (63.6%). The confirmed objective response rate is 36.4%. Median progression-free survival is 8.2 months. Median duration of response is unreached. Subgroup analyses were performed by clinicopathological features and prior treatments. In patients with platinum-refractory diseases (n = 53), confirmed objective response rate is 34.0%, median progression-free survival is 9.2 months and median duration of response is 13.3 months. Responses are observed in distinct 20ins variants and intracranial lesions. Intracranial disease control rate is 87.5%. Confirmed intracranial objective response rate is 25%.© 2023. The Author(s).

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出版当年[2023]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
最新[2025]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
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出版当年[2023]版：
Q1 MULTIDISCIPLINARY SCIENCES
最新[2024]版：
Q1 MULTIDISCIPLINARY SCIENCES

影响因子： 最新[2024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] 出版后一年[2024版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Shen Zhao,Wu Zhuang,Baohui Han,et al.Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer[J].NATURE COMMUNICATIONS.2023,14(1):doi:10.1038/s41467-023-39139-4.
APA：
Shen Zhao,Wu Zhuang,Baohui Han,Zhengbo Song,Wei Guo...&Wenfeng Fang.(2023).Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer.NATURE COMMUNICATIONS,14,(1)
MLA：
Shen Zhao,et al."Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer".NATURE COMMUNICATIONS 14..1(2023)

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