학술논문
Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies
Document Type
Article
Author
Yang, Sheng ; Wu, Shiman ; Zhao, Yanqiu ; Chen, Gongyan ; Zhu, Bo ; Li, Xingya ; Wang, Ke ; Shi, Jianhua ; Cang, Shundong ; Yao, Wenxiu ; Fan, Yun ; Fang, Jian ; Zhang, Liangming ; Zhou, Jianying ; Wu, Lin ; Zheng, Rongsheng ; Huang, Meijuan ; Pan, Yueyin ; Yang, Zhixiong ; Sun, Meili ; Yu, Huiqing ; Wang, Donglin ; Huang, Jianan ; Wang, Lijun ; Shu, Yongqian ; Chen, Zhaohong ; Liu, Chunling ; Li, Jingzhang ; Liu, Jiwei ; Sun, Shenghua ; Guo, Yanzhen ; Meng, Zili ; Liu, Zhefeng ; Han, Zhigang ; Wu, Gang ; Lu, Hong ; Ma, Rui ; Hu, Sheng ; Zhao, Guofang ; Zhang, Longzhen ; Liu, Zheng ; Xie, Congying ; Zhong, Diansheng ; Zhao, Hui ; Bi, Minghong ; Yi, Shanyong ; Guo, Shuliang ; Yi, Tienan ; Li, Wen ; Lin, Yingcheng ; Chen, Zhendong ; Zhuang, Zhixiang ; Guo, Zhongliang ; Greco, Michael ; Wang, Tingting ; Zhou, Anqi ; Shi, Yuankai
Source
In Lung Cancer June 2023 180
Subject
Language
ISSN
0169-5002
Abstract
Background Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) which revealed the systematic and central nervous system (CNS) antitumor activities for EGFR T790M-mutated advanced NSCLC in previous clinical studies and is further analyzed here.Methods Eligible patients from the previous phase I and phase IIb studies of rezivertinib were included for pooled analysis. Post-progressive patients who received a prescribed dosage (≥180 mg) of rezivertinib orally once daily were included in full analysis set (FAS), while those with stable, asymptomatic CNS lesions, including measurable and non-measurable ones at baseline were included in CNS full analysis set (cFAS). Patients with measurable CNS lesions were included in CNS evaluable for response set (cEFR). BICR-assessed CNS objective response rate (CNS-ORR), CNS disease control rate (CNS-DCR), CNS duration of response (CNS-DoR), CNS progression-free survival (CNS-PFS), and CNS depth of response (CNS-DepOR) were evaluated.Results 355 patients were included in FAS, among whom 150 and 45 patients were included in cFAS and cEFR. This pooled analysis showed the CNS-ORR was 32.0% (48/150; 95% CI: 24.6–40.1%) and the CNS-DCR was 42.0% (63/150; 95% CI: 34.0–50.3%) in cFAS, while that in cEFR were 68.9% (31/45; 95% CI: 53.4–81.8%) and 100% (45/45; 95% CI: 92.1–100.0%). In cEFR, the median CNS-DepOR and the mean of CNS-DepOR were -52.0% (range: -100.0 to 16.1%) and -46.8% (95% CI: –55.5 to -38.1%). In cFAS, the median CNS-DoR and CNS-PFS were 13.8 (95% CI: 9.6-not calculable [NC]) and 16.5 (95% CI: 13.7-NC) months.Conclusions Rezivertinib demonstrated encouraging clinical CNS efficacy among advanced NSCLC patients with EGFR T790M mutation and CNS metastases.