Ivonescimab Plus Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant

作者：HARMONi-A Study Investigators, Wen‐Feng Fang, Yuanyuan Zhao, Yongzhong Luo, Runxiang Yang, Yan Huang, Zhiyong He, Hui Zhao, Mingjun Li, Kai Li, Qibin Song, Xiaobo Du, Yulan Sun, Wei Li, Fei Xu, Zhiyu Wang, Kunning Yang, Yun Fan, Baogang Liu, Hongyun Zhao, Ying Hu, Lee Jia, Xu Shen, Tienan Yi, Dongqing Lv, Haitao Lan, Mengxia Li, Wenhua Liang, Yongsheng Wang, Hui Yang, Yuming Jia, Yuan Chen, Jun‐Guo Lu, Jifeng Feng, Chunling Liu, Ming Zhou, Jianya Zhou, Xianling Liu, Ningning Zhou, Ming He, Xiaorong Dong, Hualin Chen, Yongxing Chen, Haichuan Su, Xiaoling Li, Zhihong Zhang, Lei Yang, Ying Cheng, Likun Chen, Xue Hou, Yu Zhang, Jun Guo, Zhen Wang, Hong Lu, Di Wu, Weineng Feng, Wen Li, Jian‐An Huang, Yan Wang, Xia Song, Jiewen Peng, Laiyu Liu, Yubiao Guo, Wenting Li, Dongmei Lu, Mingxiu Hu, Zhongmin Maxwell Wang, Baiyong Li, Michelle Xia, Li Zhang · 发表于：JAMA · 年份：2024 · DOI：10.1001/jama.2024.10613 · 被引用次数：186 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Cancer Immunotherapy and Biomarkers

Importance: For patients with non-small cell lung cancer whose disease progressed while receiving EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, particularly third-generation TKIs, optimal treatment options remain limited. Objective: To compare the efficacy of ivonescimab plus chemotherapy with chemotherapy alone for patients with relapsed advanced or metastatic non-small cell lung cancer with the epidermal growth factor receptor (EGFR) variant. Design, Setting, and Participants: Double-blind, placebo-controlled, randomized, phase 3 trial at 55 sites in China enrolled participants from January 2022 to November 2022; a total of 322 eligible patients were enrolled. Interventions: Participants received ivonescimab (n = 161) or placebo (n = 161) plus pemetrexed and carboplatin once every 3 weeks for 4 cycles, followed by maintenance therapy of ivonescimab plus pemetrexed or placebo plus pemetrexed. Main Outcomes and Measures: The primary end point was progression-free survival in the intention-to-treat population assessed by an independent radiographic review committee (IRRC) per Response Evaluation Criteria in Solid Tumors version 1.1. The results of the first planned interim analysis are reported. Results: Among 322 enrolled patients in the ivonescimab and placebo groups, the median age was 59.6 vs 59.4 years and 52.2% vs 50.9% of patients were female. As of March 10, 2023, median follow-up time was 7.89 months. Median progression-free survival was 7.1 (95% CI, 5.9-8.7) mon...