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作者

Jin-Ji Yang, Yan Zhang, Lin Wu, Jie Hu, Zhe-Hai Wang, Jing-Hua Chen, Yun Fan, Gen Lin, Qi-Ming Wang, Yu Yao, Jun Zhao, Yuan Chen, Jian Fang, Yong Song, Wei Zhang, Ying Cheng, Ren-Hua Guo, Xing-Ya Li, He-Peng Shi, Wei-Zhe Xue, Di Han, Pei-Long Zhang, Yi-Long Wu

作者单位

Affiliations ¹ Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. ² Lung Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China. ³ Division of Thoracic Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China. ⁴ Department of Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha, China. ⁵ Pulmonary and Critical Care Medicine, Zhongshan Hospital Affiliated to Fudan University, Shanghai, China. ⁶ Department of Medical Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China. ⁷ Department of Medical Oncology, Shenzhen People's Hospital, Jinan University, Shenzhen, China. ⁸ Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. ⁹ Department of Internal Medicine-Oncology, Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, China. ¹⁰ Department of Respiratory, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China. ¹¹ Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. ¹² Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology, Peking University Cancer Hospital & Institute, Beijing, China. ¹³ Department of Lung Cancer, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. ¹⁴ Department of Lung Cancer, Peking University Cancer Hospital & Institute, Beijing, China. ¹⁵ Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. ¹⁶ Department of Lung Cancer, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. ¹⁷ Department of Lung Cancer, Jilin Cancer Hospital, Changchun, China. ¹⁸ Department of Lung Cancer, Jiangsu Provincial People's Hospital Nanjing, China. ¹⁹ Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. ²⁰ Beijing Pearl Biotechnology Co, Ltd, Beijing, China. ²¹ Department of Clinical Operation, Beijing Pearl Biotechnology Co, Ltd, Beijing, China. ²² Department of Medicine, Beijing Pearl Biotechnology Co, Ltd, Beijing, China.

刊名

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

年份

2024

卷号

Vol.42 No.31

页码

3680-3691

ISSN

1527-7755

摘要

Purpose: The KUNPENG study aimed to evaluate the efficacy and safety of vebreltinib , a potent and highly selective inhibitor of c-mesenchymal-epithelial transition , in patients with locally advanced or metastatic non-small cell lung cancer harboring c-Met alterations. Methods: This multicenter, multicohort, open-label, single-arm, phase II trial enrolled patients with c-Met dysregulated, locally advanced or metastatic NSCLC from January 2020 to August 2022 across 17 centers. Cohort 1 included...更多

Purpose: The KUNPENG study aimed to evaluate the efficacy and safety of vebreltinib , a potent and highly selective inhibitor of c-mesenchymal-epithelial transition , in patients with locally advanced or metastatic non-small cell lung cancer harboring c-Met alterations. Methods: This multicenter, multicohort, open-label, single-arm, phase II trial enrolled patients with c-Met dysregulated, locally advanced or metastatic NSCLC from January 2020 to August 2022 across 17 centers. Cohort 1 included patients with MET exon 14 skipping -mutant NSCLC who had not previously received MET inhibitors. Participants were administered vebreltinib at a dosage of 200 mg twice a day in 28-day cycles. The primary end point was the objective response rate , and the key secondary end point was the duration of response , both evaluated by a blinded independent review committee according to the RECIST version 1.1. Results: As of August 9, 2022, 52 patients had been enrolled in cohort 1, of whom 35 were treatment-naïve. The ORR reached 75% . Among treatment-naïve patients, the ORR was 77.1% , and in previously treated patients, it was 70.6% . The disease control rate was 96.2%, with a median DoR of 15.9 months, a median progression-free survival of 14.1 months, and a median overall survival of 20.7 months. The most common treatment-related adverse events were peripheral edema , QT prolongation , and elevated serum creatinine . Conclusion: Vebreltinib has shown promising efficacy and a favorable safety profile in patients with METex14-mutant NSCLC.收起

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