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Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trialстатья
Статья опубликована в высокорейтинговом журнале
Статья опубликована в журнале из списка Web of Science и/или Scopus- Авторы: Gogishvili Miranda, Melkadze Tamar, Makharadze Tamta, Giorgadze Davit, Dvorkin Mikhail, Penkov Konstantin, Laktionov Konstantin, Nemsadze Gia, Nechaeva Marina, Rozhkova Irina, Kalinka Ewa, Gessner Christian
- Журнал: Nature Medicine
- Год издания: 2022
- Издательство: Nature Publishing Group
- Местоположение издательства: United Kingdom
- Первая страница: 2374
- Последняя страница: 2382
- Аннотация: First-line cemiplimab (anti-programmed cell death-1 (PD-1)) monotherapy has previously shown significant improvementin overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with advanced non-small celllung cancer (aNSCLC) and PD-ligand 1 (PD-L1) expression ≥50%. EMPOWER-Lung 3 (NCT03409614), a double-blind,placebo-controlled, phase 3 study, examined cemiplimab plus platinum-doublet chemotherapy as first-line treatment foraNSCLC, irrespective of PD-L1 expression or histology. In this study, 466 patients with stage III/IV aNSCLC without EGFR,ALK or ROS1 genomic tumor aberrations were randomized (2:1) to receive cemiplimab 350 mg (n= 312) or placebo (n= 154)every 3 weeks for up to 108 weeks in combination with four cycles of platinum-doublet chemotherapy (followed by pemetrexedmaintenance as indicated). In total, 57.1% (266/466 patients) had non-squamous NSCLC, and 85.2% (397/466 patients) hadstage IV disease. The primary endpoint was OS. The trial was stopped early per recommendation of the independent datamonitoring committee, based on meeting preset OS efficacy criteria: median OS was 21.9 months (95% confidence interval(CI), 15.5–not evaluable) with cemiplimab plus chemotherapy versus 13.0 months (95% CI, 11.9–16.1) with placebo plus chemotherapy (hazard ratio (HR) = 0.71; 95% CI, 0.53–0.93; P= 0.014). Grade ≥3 adverse events occurred with cemiplimab pluschemotherapy (43.6%, 136/312 patients) and placebo plus chemotherapy (31.4%, 48/153 patients). Cemiplimab is only thesecond anti-PD-1/PD-L1 agent to show effica
- Добавил в систему: Лактионов Константин Константинович