Mefatinib versus gefitinib as a first-line treatment for EGFR-mutated non-small cell lung cancer: a randomized, double-blind, multicenter phase III study.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Yu Jia, Xiong Anwen, Wang Qiming, Chen Jianhua, Niu Hongrui, Zhou Chengzhi, Tian Panwen, Zhuang Wu, Li Jie, Wang Jing, Lu Junguo, Gu Kangsheng, Shi Jinsheng, Guo Jun, Di Yonghui, Lv Dongqing, Sun Debin, Cao Liming, Yang Zhixiong, Wu Jingxun, Miao Liyun, Pan Yueyin, Li Chong, Wu Xiaohong, Yin Jie, Wang Xiang, Sun Meili, He Miao, Cang Shundong, Fang Haohui, Chen Ping, Zhang Min, Yang Xinmei, Zhao Hui, Feng Jian, Ma Xuezhen, Hu Sheng, Lu Jian, Zhao Xin, Zhuang Zhixiang, Sun Yilan, Sun Xu, Yu Bing, Zhu Chaonan, Chen Jianghua, Xu June, Wang Kai, Zhou Caicun
Аннотация
Mefatinib, a novel second-generation epidermal growth factor (EGFR) tyrosine kinase inhibitor that has shown promising antitumor activity in targeting non-small cell lung cancer (NSCLC) with common and uncommon EGFR-activating mutations. In this phase III, randomized, double-blind trial in China, 336 eligible patients with advanced nonsquamous NSCLC harboring EGFR L858R or exon 19 deletion (ex19del) were assigned (2:1) to receive either mefatinib (60 mg daily, n = 223) or gefitinib (250 mg daily, n = 113). The primary endpoint was progression-free survival (PFS), assessed by an independent review committee (IRC). The trial is registered with chinadrugtrials.org.cn (CTR20192297). After a median follow-up of 15.9 months for mefatinib and 18.5 months for gefitinib, mefatinib demonstrated a significantly longer median IRC-assessed PFS compared to gefitinib (13.7 vs. 9.7 months; hazard ratio [HR] = 0.68; 95% confidence intervals [CI]: 0.53-0.87; p = 0.002). The 30-month overall survival rate was 60.2% for mefatinib and 54.3% for gefitinib. Patients with EGFR ex19del had comparable PFS for both treatment arms (p > 0.100), whereas patients with EGFR L858R had significantly longer median PFS when treated with mefatinib than gefitinib (13.7 vs 8.3 months HR = 0.55 [95% CI: 0.38-0.78]; p = 0.001). Patients with EGFR L858R had a 30-month overall survival rate of 56.6% with mefatinib and 43.7% with gefitinib. Treatment-related adverse events ≥grade 3 were reported in 45.7% of the mefatinib group and 24.8% of the gefitinib group. No new safety signals were observed for mefatinib. Mefatinib demonstrated superior efficacy to gefitinib with a similar tolerability profile in the first-line treatment of EGFR-mutated advanced NSCLC.