Data from A Novel Third-generation EGFR Tyrosine Kinase Inhibitor Abivertinib for EGFR T790M-mutant Non–Small Cell Lung Cancer: a Multicenter Phase I/II Study
Year: 2023
Type: other
Abstract: Purpose: To establish recommended phase II dose (RP2D) in phase I and evaluate safety and efficacy of abivertinib in patients with EGFR Thr790Met point mutation (T790M)-positive(+) non–small cell lung cancer (NSCLC) with disease progression from prior EGFR inhibitors in phase II. Patients and Methods: This multicenter, open-label study included 367 adult Chinese patients. Abivertinib at doses of 50 mg twice a day to 350 mg twice a day was evaluated in phase I in continual 28-day cycles, and the RP2D of 300 mg twice a day was used in phase II in continual 21-day cycles. Primary endpoints include RP2D in phase I and objective response rate (ORR) at RP2D in phase II. Results: The RP2D of 300 mg twice a day for abivertinib was established based on pharmacokinetics, efficacy, and safety profiles across doses in phase I. In phase II, 227 patients received RP2D for a median treatment duration of 24.6 weeks (0.43–129). Among 209 response–evaluable patients, confirmed ORR was 52.2% [109/209; 95% confidence interval (CI): 45.2–59.1]. Disease control rate (DCR) was 88.0% (184/209; 95% CI: 82.9–92.1). The median duration of response (DoR) and progression-free survival (PFS) was 8.5 months (95% CI: 6.1–9.2) and 7.5 months (95% CI: 6.0–8.8), respectively. The median overall survival (OS) was 24.9 months [95% CI: 22.4–not reachable (NR)]. All (227/227) patients reported at least 1 adverse event (AE), with 96.9% (220/227) of treatment-related AEs. Treatment-related serious AEs were reported in 13.7% (31/227) of patients. Death was reported in 4.4% (10/227) of patients, and none was deemed as treatment-related. Conclusions: Abivertinib of 300 mg twice a day demonstrated favorable clinical efficacy with manageable side effects in patients with EGFR T790M+ NSCLC.
Authors: Qing Zhou, Lin Wu, Pei Hu, Tongtong An, Jianying Zhou, Li Zhang, Xiao-Qing Liu, Feng Luo, Xin Zheng, Ying Cheng, Nong Yang, Junling Li, Jifeng Feng, Baohui Han, Yong Song, Kai Wang, Jian Fang, Hong Zhao, Yongqian Shu, Xiao-Yan Lin, Zhihong Chen, Bin Gan, Wan-Hong Xu, Wei Tang, Xiaoying Zhang, Jin-Ji Yang, Xiao Xu, Yi-Long Wu
Institutions: Guangdong Academy of Medical Sciences, Guangdong Provincial People's Hospital, Central South University, Hunan Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital, Peking University Cancer Hospital, First Affiliated Hospital Zhejiang University, Zhejiang University, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Chinese PLA General Hospital, West China Hospital of Sichuan University, Jilin Province Tumor Hospital, Cancer Foundation of China, Jiangsu Cancer Hospital, Nanjing Medical University, Shanghai Jiao Tong University, Shanghai Chest Hospital, Nanjing General Hospital of Nanjing Military Command, Nanjing University, Second Affiliated Hospital of Zhejiang University, Jiangsu Province Hospital, Union Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4361958928