Bispecific Antibody Ivonescimab Added to Chemotherapy in EGFR-Variant Non-Small Cell Lung Cancer: The HARMONi-A Randomized Clinical Trial.
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HARMONi-A Study Investigators, Fang Wenfeng, Zhao Yuanyuan, Luo Yongzhong, Yang Runxiang, Huang Yan, He Zhiyong, Zhao Hui, Li Mingjun, Li Kai, Song Qibin, Du Xiaobo, Sun Yulan, Li Wei, Sun Longhua, Wang Zhiyu, Yang Kunning, Fan Yun, Liu Baogang, Zhao Hongyun, Hu Ying, Jia Li, Xu Shen, Yi Tienan, Lv Dongqing, Lan Haitao, Li Mengxia, Liang Wenhua, Wang Yongsheng, Yang Hui, Jia Yuming, Chen Yuan, Lu Junguo, Shi Meiqi, Liu Chunling, Zhou Ming, Zhou Jianya, Liu Xianling, Zhou Ningning, He Ming, Dong Xiaorong, Chen Hualin, Chen Yongxing, Su Haichuan, Li Xiaoling, Zhang Zhihong, Yang Lei, Liu Ying, Chen Likun, Hou Xue, Zhang Yu, Guo Jun, Ma Ruiqiang, Lu Hong, Wu Di, Feng Weineng, Li Wen, Huang Jianan, Wang Yan, Song Xia, Peng Jiewen, Liu Laiyu, Guo Yubiao, Li Wenting, Xia Mengying, Lu Dongmei, Hu Mingxiu, Wang Zhongmin Maxwell, Li Baiyong, Xia Michelle Y, Zhang Li
Аннотация
OBJECTIVE: To provide final overall results of a trial assessing whether adding ivonescimab (a bispecific antibody targeting programmed cell death protein 1 and vascular endothelial growth factor) to chemotherapy improves overall survival in this population.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled phase 3 trial conducted at 55 sites in China. From January 25 to November 2, 2022, a total of 322 adult patients with locally advanced or metastatic EGFR-variant nonsquamous NSCLC who had received prior EGFR-TKI therapy were enrolled. The data cutoff date was April 12, 2025.
INTERVENTIONS: Patients were randomized 1:1 to receive ivonescimab (20 mg/kg; n = 161) or placebo (n = 161) plus chemotherapy with pemetrexed and carboplatin once every 3 weeks for 4 cycles, followed by maintenance therapy.
MAIN OUTCOMES AND MEASURES: This final results report focuses on overall survival, the key secondary end point, tested in a hierarchical manner (the primary end point was progression-free survival assessed by an independent radiology review committee).
RESULTS: The 322 enrolled patients had a median age of 59.4 years, and 51.6% were female. During a median follow-up of 32.5 months, ivonescimab plus chemotherapy improved overall survival compared with chemotherapy alone (median survival, 16.8 months vs 14.1 months; stratified hazard ratio, 0.74; 95% CI, 0.58-0.95; P = .02). The absolute difference in median overall survival was 2.7 months. Estimated 30-month survival rates were 29.1% (95% CI, 22.1%-36.4%) with ivonescimab and 18.4% (95% CI, 12.8%-24.8%) with placebo. Grade 3 or higher treatment-emergent adverse events occurred in 67.1% and 54.7% of patients receiving ivonescimab and placebo, respectively.
CONCLUSIONS AND RELEVANCE: Ivonescimab plus chemotherapy provided a statistically significant and clinically meaningful improvement in overall survival with an acceptable safety profile in patients with EGFR-variant NSCLC after EGFR-TKI therapy.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05184712.