Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS).
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Lu Shun, Dong Xiaorong, Jian Hong, Chen Jianhua, Chen Gongyan, Sun Yuping, Ji Yinghua, Wang Ziping, Shi Jianhua, Lu Junguo, Chen Shaoshui, Lv Dongqing, Zhang Guojun, Liu Chunling, Li Juan, Yu Xinmin, Lin Zhong, Yu Zhuang, Wang Zhehai, Cui Jiuwei, Xu Xingxiang, Fang Jian, Feng Jifeng, Xu Zhi, Ma Rui, Hu Jie, Yang Nong, Zhou Xiangdong, Wu Xiaohong, Hu Chengping, Zhang Zhihong, Lu You, Hu Yanping, Jiang Liyan, Wang Qiming, Guo Renhua, Zhou Jianying, Li Baolan, Hu Chunhong, Tong Wancheng, Zhang Helong, Ma Lin, Chen Yuan, Jie Zhijun, Yao Yu, Zhang Longzhen, Weng Jie, Li Weidong, Xiong Jianping, Ye Xianwei, Duan Jianchun, Yang Haihua, Sun Meili, Wei Hongying, Wei Jiawei, Zhang Zheyu, Wu Qiong
Аннотация
METHODS: Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double-blinded fashion. Patients with asymptomatic, stable CNS metastases were included. Follow-up imaging of the same modality as the initial CNS imaging was performed every 6 weeks for 15 months, then every 12 weeks. CNS response was assessed by a neuroradiological blinded, independent central review (neuroradiological-BICR). The primary endpoint for this subgroup analysis was CNS progression-free survival (PFS).
RESULTS: Of the 429 patients enrolled and randomized in the ANEAS study, 106 patients were found to have CNS metastases (CNS Full Analysis Set, cFAS) at baseline by neuroradiological-BICR, and 60 of them had CNS target lesions (CNS Evaluable for Response, cEFR). Treatment with aumolertinib significantly prolonged median CNS PFS compared with gefitinib in both cFAS (29.0 vs. 8.3 months; hazard ratio [HR] = 0.31; 95% confidence interval [CI], 0.17-0.56; P < 0.001) and cEFR (29.0 vs. 8.3 months; HR = 0.26; 95% CI, 0.11-0.57; P < 0.001). The confirmed CNS overall response rate in cEFR was 85.7% and 75.0% in patients treated with aumolertinib and gefitinib, respectively. Competing risk analysis showed that the estimated probability of CNS progression without prior non-CNS progression or death was consistently lower with aumolertinib than with gefitinib in patients with and without CNS metastases at baseline. No new safety findings were observed.
CONCLUSIONS: These results indicate a potential advantage of aumolertinib over gefitinib in terms of CNS PFS and the risk of CNS progression in patients with EGFR-mutated advanced NSCLC with baseline CNS metastases.
TRIAL REGISTRATION: ClinicalTrials.gov number, NCT03849768.