Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies
Year: 2023
Type: article
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.
Source: Lung Cancer
Authors: Sheng Yang, Shiman Wu, Yanqiu Zhao, Gongyan Chen, Bo Zhu, Xingya Li, Ke Wang, Jianhua Shi, Shundong Cang, Wenxiu Yao, Yun Fan, Jian Fang, Liangming Zhang, Jianying Zhou, Lin Wu, Rongsheng Zheng, Meijuan Huang, Yueyin Pan, Zhixiong Yang, Meili Sun, Huiqing Yu, Donglin Wang, Jianan Huang, Lijun Wang, Yongqian Shu, Zhaohong Chen, Chunling Liu, Jingzhang Li, Jiwei Liu, Shenghua Sun, Yanzhen Guo, Zili Meng, Zhefeng Liu, Zhigang Han, Gang Wu, Hong Lu, Rui Ma, Sheng Hu, Guofang Zhao, Longzhen Zhang, Zheng Liu, Congying Xie, Diansheng Zhong, Hui Zhao, Minghong Bi, Shanyong Yi, Shuliang Guo, Tienan Yi, Wen Li, Yingcheng Lin, Zhendong Chen, Zhixiang Zhuang, Zhongliang Guo, Michael Greco, Tingting Wang, Anqi Zhou, Yuankai Shi
Institutions: Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Hospital of Chinese Academy of Medical Sciences, Shanxi Medical University, First Hospital of Shanxi Medical University, Zhengzhou University, Third Affiliated Hospital of Harbin Medical University, Army Medical University, Xinqiao Hospital, First Affiliated Hospital of Zhengzhou University, West China Hospital of Sichuan University, Henan Provincial People's Hospital, Sichuan Cancer Hospital, Zhejiang Cancer Hospital, Peking University Cancer Hospital, Yuhuangding Hospital, First Affiliated Hospital Zhejiang University, Zhejiang University, Central South University, Hunan Cancer Hospital, First Affiliated Hospital of Bengbu Medical College, Sichuan University, West China Medical Center of Sichuan University, University of Science and Technology of China, Guangdong Medical College, Shandong University, Jinan Central Hospital, Chongqing University, Chongqing Cancer Hospital, First Affiliated Hospital of Soochow University, Xingtai Medical College, Jiangsu Province Hospital, Second Affiliated Hospital of Anhui Medical University, Xinjiang Medical University, Tumor Hospital of Xinjiang Medical University, Liuzhou General Hospital, First Affiliated Hospital of Dalian Medical University, Third Xiangya Hospital, First Affiliated Hospital of Henan University of Science and Technology, Huaian First People’s Hospital, Chinese PLA General Hospital, Wuhan Union Hospital, Huazhong University of Science and Technology, Henan University, Henan University Huaihe Hospital and Huaihe Clinical Institute, Liaoning Cancer Hospital & Institute, Hubei Cancer Hospital, Ningbo No. 2 Hospital, First Affiliated Hospital of Wenzhou Medical University, Tianjin Medical University General Hospital, Zhengzhou Central Hospital, The Affiliated Yongchuan Hospital of Chongqing Medical University, Hubei University of Arts and Science, Xiangyang Central Hospital, Second Affiliated Hospital of Zhejiang University, Cancer Hospital of Shantou University Medical College, Shantou University Medical College, Second Affiliated Hospital of Soochow University, Shanghai East Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,110
Awards: G5983623123, G6958683051
OpenAlex ID: W4366124138