Introduction: This exploratory subgroup analysis of the MARQUEE study evaluated the efficacy and safety of erlotinib plus tivantinib in patients with EGFR‐mutant NSCLC. Methods: Patients with advanced, nonsquamous, EGFR and mesenchymal‐epithelial transition inhibitor–naive NSCLC previously treated with one or two lines of systemic therapy were randomized to oral erlotinib (150 mg once daily) plus tivantinib (360 mg twice daily) or to erlotinib plus placebo. The primary end point was overall survival. Results: Among 1048 patients enrolled, 109 (10.4%) had EGFR‐mutant disease. Erlotinib plus tivantinib improved progression‐free survival in this subpopulation; median progression‐free survival was 13.0 months for erlotinib plus tivantinib (n = 56) and 7.5 months for erlotinib plus placebo (n = 53) (hazard ratio = 0.49, 95% confidence interval: 0.31–0.77). Deaths occurred in 73 patients (67%), and median overall survival was 25.5 months in the erlotinib plus tivantinib arm versus 20.3 months in the erlotinib plus placebo arm (hazard ratio = 0.68, 95% confidence interval: 0.43–1.08). Common adverse events included diarrhea, rash, and asthenia. Neutropenia and febrile neutropenia were more common with erlotinib plus tivantinib. Conclusions: Erlotinib plus tivantinib was tolerable and showed improved efficacy over erlotinib monotherapy in previously treated EGFR‐mutant NSCLC.

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简要报告：Tivantinib 联合厄洛替尼与厄洛替尼单药治疗 EGFR 突变 NSCLC：3 期 MARQUEE 研究的探索性分析

简介：这项 MARQUEE 研究的探索性亚组分析评估了厄洛替尼联合 tivantinib 在 EGFR 突变 NSCLC 患者中的疗效和安全性。方法：先前接受过一两线全身治疗的晚期非鳞状 EGFR 和间充质上皮转化抑制剂初治 NSCLC 患者被随机分配至口服厄洛替尼（150 mg 每天一次）加替凡替尼（360 mg 每天两次）或厄洛替尼加上安慰剂。主要终点是总生存期。结果：在纳入的 1048 名患者中，109 名 (10.4%) 患有 EGFR 突变疾病。厄洛替尼加 tivantinib 改善了该亚群的无进展生存期；厄洛替尼联合替凡替尼（n = 56）的中位无进展生存期为 13.0 个月，厄洛替尼联合安慰剂（n = 53）为 7.5 个月（风险比 = 0.49，95% 置信区间：0.31–0）。77)。73 名患者 (67%) 发生死亡，厄洛替尼加替凡替尼组的中位总生存期为 25.5 个月，而厄洛替尼加安慰剂组为 20.3 个月（风险比 = 0.68，95% 置信区间：0.43–1.08）。常见的不良事件包括腹泻、皮疹和虚弱。中性粒细胞减少症和发热性中性粒细胞减少症在厄洛替尼加 tivantinib 中更常见。结论：厄洛替尼联合 tivantinib 在既往接受过治疗的 EGFR 突变 NSCLC 中与厄洛替尼单药治疗相比是可耐受的，并显示出更高的疗效。中性粒细胞减少症和发热性中性粒细胞减少症在厄洛替尼加 tivantinib 中更常见。结论：厄洛替尼联合 tivantinib 在既往接受过治疗的 EGFR 突变 NSCLC 中与厄洛替尼单药治疗相比是可耐受的，并显示出更高的疗效。中性粒细胞减少症和发热性中性粒细胞减少症在厄洛替尼加 tivantinib 中更常见。结论：厄洛替尼联合 tivantinib 在既往接受过治疗的 EGFR 突变 NSCLC 中与厄洛替尼单药治疗相比是可耐受的，并显示出更高的疗效。