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Vebreltinib for Advanced Non-Small Cell Lung Cancer Harboring c-Met Exon 14 Skipping Mutation: A Multicenter, Single-Arm, Phase II KUNPENG Study

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机构： [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.

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The KUNPENG study aimed to evaluate the efficacy and safety of vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (MET), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring c-Met alterations.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 (METex14)-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 (ORR), and the key secondary end point was the duration of response (DoR), both evaluated by a blinded independent review committee according to the RECIST version 1.1.As of August 9, 2022, 52 patients had been enrolled in cohort 1, of whom 35 (67.3%) were treatment-naïve. The ORR reached 75% (95% CI, 61.1 to 86). Among treatment-naïve patients, the ORR was 77.1% (95% CI, 59.9 to 89.6), and in previously treated patients, it was 70.6% (95% CI, 44.0 to 89.7). 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 (82.7%), QT prolongation (30.8%), and elevated serum creatinine (28.8%).Vebreltinib has shown promising efficacy and a favorable safety profile in patients with METex14-mutant NSCLC.

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大类 | 1 区

医学

小类 | 1 区肿瘤学

最新[2023]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

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第一作者机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China.

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