Efficacy and Safety of Limertinib (ASK120067) in Patients With Locally Advanced or Metastatic EGFR Thr790Met-Mutated NSCLC: A Multicenter, Single-Arm, Phase 2b Study

作者：Yuankai Shi, Baolan Li, Lin Wu, Yueyin Pan, Zhijie Pan, Yunpeng Liu, Yun Fan, Yinghua Ji, Jian Fang, Qin Shi, Jianhua Shi, Hongjun Gao, Yanping Hu, Xiang Wang, Zhiyong He, Rui Ma, Yu Zhang, Da Jiang, Yuansong Bai, Yi Zhang, Linian Huang, Tong Zhou, Hailong Liu, Daqing Wang, Qinglian Wen, Gongyan Chen, Aimin Zang, Xiuwen Wang, Xinri Zhang, Jianbing Hu, Runxiang Yang, Guo‐Jun Zhang, Kangsheng Gu, Lin Wang, Qiming Wang, Zonghui Wei, Li Zeng, Hongda Lu, Helong Zhang, Hongyu Chen, Tingting Song · 发表于：Journal of Thoracic Oncology · 年份：2022 · DOI：10.1016/j.jtho.2022.05.011 · 被引用次数：30 · 研究领域：Lung Cancer Treatments and Mutations、Colorectal Cancer Treatments and Studies、HER2/EGFR in Cancer Research

INTRODUCTION: Limertinib (ASK120067) is a newly developed third-generation EGFR tyrosine kinase inhibitor targeting both sensitizing EGFR and EGFR Thr790Met (T790M) mutations. This study aimed to evaluate the efficacy and safety of limertinib in patients with locally advanced or metastatic EGFR T790M-mutated NSCLC. METHODS: This is a single-arm, open-label, phase 2b study conducted at 62 hospitals across the People's Republic of China. Patients with locally advanced or metastatic NSCLC with centrally confirmed EGFR T790M mutations in tumor tissue or blood plasma who progressed after first- or second-generation EGFR tyrosine kinase inhibitors or with primary EGFR T790M mutations were enrolled. Patients received limertinib 160 mg orally twice daily until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) assessed by independent review committee per the Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end points included disease control rate, progression-free survival (PFS), duration of response (DoR), overall survival, and safety. Safety was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. RESULTS: From July 16, 2019, to March 10, 2021, a total of 301 patients were enrolled and started the treatment of limertinib. All patients entered the full analysis set and safety set. By the data cutoff date on September 9, 2021, 76 (25.2%) remained on treatm...