医学
T790米
内科学
肺癌
肺
合并分析
中枢神经系统
肿瘤科
癌症
表皮生长因子受体
生物信息学
病理
癌症研究
荟萃分析
吉非替尼
生物
作者
Xingsheng Hu,Shucai Zhang,Zhiyong Ma,Jifeng Feng,Lin Wu,Dongqing Lv,Jianying Zhou,Xiaodong Zhang,Li Liu,Yu Qin,Wangjun Liao,Yiping Zhang,Xiang Wang,Ying Cheng,Niu Huang,Ziping Wang,Dong Wang,Cheng Huang,Chunling Liu,Hui Zhao,Jian Feng,Jingzhang Li,Kejing Ying,Nong Yang,Shukui Qin,Jie Hu,Fei Liu,Yong Jiang,Nan Guo,Yuankai Shi
出处
期刊:BMC Medicine
[Springer Nature]
日期:2023-04-28
卷期号:21 (1)
被引量:4
标识
DOI:10.1186/s12916-023-02865-z
摘要
Furmonertinib (AST2818) is a brain penetrant pan-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both EGFR sensitizing mutations and T790M mutation. We report the pooled central nervous system (CNS) efficacy data of furmonertinib in patients with EGFR T790M mutated non-small cell lung cancer (NSCLC) from two phase 2 studies.This was a pooled, post-hoc analysis of two phase 2 studies (NCT03127449 [phase 2a study of furmonertinib], NCT03452592 [phase 2b study of furmonertinib]). In the phase 2a study, patients received furmonertinib 40 mg, 80 mg, 160 mg, or 240 mg orally once daily. In the phase 2b study, all patients received furmonertinib 80 mg orally once daily. CNS efficacy of furmonertinib was analyzed in patients with baseline CNS lesions by an independent review center per Response Evaluation Criteria in Solid Tumors version 1.1.A total of 132 patients with baseline CNS metastases were included in this analysis. In 52 patients with measurable CNS lesions, CNS objective response rates were zero (0/1), 65% (22/34), 85% (11/13), and 25% (1/4), and CNS disease control rates were zero (0/1), 97% (33/34), 100% (13/13), and 100% (4/4) in the 40 mg, 80 mg, 160 mg, and 240 mg orally once daily group, respectively. In patients with measurable or non-measurable CNS lesions, median CNS progression-free survival was 2.8 months (95% confidence interval [CI] 1.4-8.3), 11.6 months (95% CI 8.3-13.8), 19.3 months (95% CI 5.5-not available [NA]), and not reached (95% CI 2.8 months-NA) in the 40 mg, 80 mg, 160 mg, and 240 mg orally once daily group, respectively.Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutated NSCLC.Both studies were registered on ClinicalTrial.gov. The phase 2a study was registered with NCT03127449 on April 25, 2017; The phase 2b study was registered with NCT03452592 on March 2, 2018.