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Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial

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收录情况： ◇ SCIE

作者：
Yu Yongfeng[1] * ; Zhou Jianya[2] ; Li Xingya[3] ; Goto Koichi[4] ; Min Xuhong[5] ; Nishino Kazumi[6] ; Cui Jiuwei[7] ; Wu Lin[8] ; Sakakibara Jun[9] ; Shu Yongqian[10] ; Dong Xiaorong[11] ; Li Lu[12] ; Yoneshima Yasuto[13] ; Zhou Chengzhi[14] ; Li Xiaoling[15] ; Zhang Yiping[16] ; Huang Dingzhi[17] ; Zang Aimin[18] ; Zhang Wei[19] ; Wang Xiuwen[20] ; Zhang Li[21] ; Bai Chong[22] ; Fang Jian[23] ; Cao Lejie[24] ; Zhao Yanqiu[25] ; Yu Yan[26] ; Shi Meiqi[27] ; Zhong Diansheng[28] ; Li Fugen[29] ; Li Meng[30] ; Wu Qiuxia[29] ; Zhou Jun[29] ; Sun Minghui[29] ; Lu Shun[1,*1] ;
机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [2]Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. [3]Oncology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [4]Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. [5]Radiology Intervention Department, Anhui Chest Hospital, Hefei, China. [6]Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan. [7]Oncology Department, The First Bethune Hospital of Jilin University, Changchun, China. [8]Second Department of Thoracic Medicine, Hunan Cancer Hospital, Changsha, China. [9]Respiratory Medicine, Hokkaido University Hospital, Sapporo, Japan. [10]Oncology Department, Jiangsu Province Hospital, Nanjing, China. [11]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [12]Lung Cancer Center, West China Hospital of Sichuan University, Chengdu, China. [13]Respiratory Medicine, Kyushu University Hospital, Fukuoka, Japan. [14]Oncology, The First Affiliate Hospital of Guangzhou Medical University, Guangzhou, China. [15]Thoracic Medicine, Liaoning Cancer Hospital & Institute, Shenyang, China. [16]Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [17]Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China. [18]Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China. [19]Pneumology Department/Institute Office, The First Affiliated Hospital of Nanchang University, Nanchang, China. [20]Oncology, Qilu Hospital of Shandong University, Jinan, China. [21]Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Beijing, China. [22]Pneumology Department, Changhai Hospital of Shanghai, Shanghai, China. [23]Thoracic Oncology Second Department, Beijing Cancer Hospital, Beijing, China. [24]Pneumology Department, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China. [25]Respiratory Department of Internal Medicine, Henan Cancer Hospital, Zhengzhou, China. [26]The Third Ward of Respiratory Medicine Department, Harbin Medical University Cancer Hospital, Harbin, China. [27]Oncology Department, Jiangsu Cancer Hospital, Nanjing, China. [28]Internal Medicine-Oncology, Tianjin Medical University General Hospital, Tianjin, China. [29]Clinical Science Department, Haihe Biopharma Co., Ltd, Shanghai, China. [30]Biostatistic and Data Science, Haihe Biopharma Co., Ltd, Shanghai, China.
出处：
DOI： 10.1016/j.eclinm.2023.101952
ISSN：

关键词： Lung cancer MET mutation MET inhibitor

摘要：
Approximately 3-4% of patients with non-small-cell lung cancer (NSCLC) have MET exon 14 (METex14) skipping mutations. We report primary results from the phase 2 stage of a phase 1b/2 study of gumarontinib, a selective, potent, oral MET inhibitor, in patients with METex14 skipping mutation-positive (METex14-positive) NSCLC.The single-arm, multicentre, open-label, phase 2 stage of the GLORY study was conducted at 42 centres across China and Japan. Adults with locally advanced or metastatic METex14-positive NSCLC received oral gumarontinib 300 mg once daily in continuous 21-day cycles until disease progression, intolerable toxicity, or withdrawal of consent. Eligible patients had failed one or two prior lines of therapy (not including a MET inhibitor), were ineligible for/refused chemotherapy, and had no genetic alterations targetable with standard therapies. The primary endpoint was objective response rate in patients with a valid baseline tumour assessment, by blinded independent review. The study was registered at ClinicalTrials.gov (NCT04270591).Between Aug 2, 2019 and Apr 28, 2021, 84 patients were enrolled and received gumarontinib (median follow-up 13.5 months [IQR 8.7-17.1]), at data cut-off (Apr 28, 2022) five patients whose METex14 status could not be confirmed by a central laboratory were excluded from the efficacy analysis. The objective response rate was 66% (95% CI 54-76) overall (n = 79), 71% (95% CI 55-83) in treatment-naïve patients (n = 44), and 60% (95% CI 42-76) in previously-treated patients (n = 35). The most common treatment-related adverse events (any grade) were oedema (67/84 patients, 80%) and hypoalbuminuria (32/84, 38%). Grade ≥3 treatment-emergent adverse events occurred in 45 (54%) patients. Treatment-related adverse events leading to permanent discontinuation occurred in 8% (7/84) of patients.Gumarontinib monotherapy had durable antitumour activity with manageable toxicity in patients with locally advanced or metastatic METex14-positive NSCLC when used in first line or later.Haihe Biopharma Co., Ltd. Supported in part by grants from the National Science and Technology Major Project of China for "Clinical Research of Gumarontinib, a highly selective MET inhibitor" (2018ZX09711002-011-003); the National Natural Science Foundation of China (82030045 to S.L. and 82172633 to YF.Y); Shanghai Municipal Science & Technology Commission Research Project (19411950500 to S.L.); Shanghai Shenkang Action Plan (16CR3005A to S.L.) and Shanghai Chest Hospital Project of Collaborative Innovation (YJXT20190105 to S.L.).© 2023 The Author(s).

基金：
This study was sponsored by Haihe Biopharma Co., Ltd. Medical writing support, funded by Haihe Biopharma, was provided by Jun Zhou and Jake Burrell PhD (Rude Health Consulting Ltd, Shanghai, China), in accordance with the Good Publication Practice 3 guidelines.
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外文
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出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

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, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
通讯作者：
通讯机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [*1]Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, No. 241, Huaihai West Road, Shanghai 200030, China.
推荐引用方式(GB/T 7714)：
Yu Yongfeng,Zhou Jianya,Li Xingya,et al.Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial[J].ECLINICALMEDICINE.2023,59:doi:10.1016/j.eclinm.2023.101952.
APA：
Yu Yongfeng,Zhou Jianya,Li Xingya,Goto Koichi,Min Xuhong...&Lu Shun.(2023).Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial.ECLINICALMEDICINE,59,
MLA：
Yu Yongfeng,et al."Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial".ECLINICALMEDICINE 59.(2023)

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