Abstract CT053: Aumolertinib with or without chemotherapy as first line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations (AENEAS2)

作者：Shun Lu, Jie Hu, Jianhua Chen, Yan Yu, Xiangjiao Meng, Xiaorong Dong, Yanping Hu, Yinghua Ji, Ying Cheng, Weibo Wang, Fangling Ning, Zhihong Zhang, Zhiye Zhang, Chunling Liu, Qiming Wang, Wei Zheng, Xiujuan Qu, Honghai Wang, Runxiang Yang, Renhua Guo, Jianhua Shi, Feng Wu, Dongqing Lv, Jian Fang, Zhi Xu, Huaqiu Shi, Haichuan Su, Yongxing Chen, Chengzhi Zhou, Junhong Zhang, Xuewen Liu, Zhaoxia Dai, Wen Li, Zili Meng, Guojun Zhang, Biyong Ren, Lin Wu, Yalun Li, Xinmin Yu, Ziping Wang, Jian Feng, Yueyin Pan, Juan Li, Xiangdong Zhou, Suxian Hu, Tongmei Zhang, Laiyu Liu, Jiming Shen, Shaonan Fan, Zhenming Chen · 发表于：Cancer Research · 年份：2025 · DOI：10.1158/1538-7445.am2025-ct053 · 被引用次数：4 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Gastric Cancer Management and Outcomes

Abstract Introduction: Aumolertinib, a third generation selective EGFR-TKI, is standard of care for the first-line treatment in advanced or metastatic NSCLC with sensitizing EGFR mutations in China. Evidence has shown that combining EGFR-TKIs with chemotherapy can improve outcomes compared to EGFR-TKIs monotherapy. AENEAS2 (NCT04923906) is a randomized, open-label, multicenter, phase 3 study assessing the efficacy and safety of aumolertinib plus chemotherapy versus aumolertinib alone as first-line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations. Methods: Patients who were naïve to treatment with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned in a 1:1 ratio to receive aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5), versus to receive aumolertinib 110 mg QD monotherapy. The primary endpoint is progression free survival (PFS) assessed by IRC (Independent Review Committee) per RECIST v1.1. Data cutoff date: 2024/06/18. Results: A total of 624 patients were randomized to aumolertinib plus chemotherapy (n=310) or aumolertinib monotherapy (n=314) and stratified according to EGFR mutation status (Ex19del verse L858R) and CNS metastases at baseline (yes versus no). Baseline characteristics were balanced between treatment arms (aumolertinib plus chemotherapy versus aumolertinib): median age (range), 58.0 (30-84)/5...