Five-Year Outcomes With Pembrolizumab Versus Chemotherapy as First-Line Therapy in Patients With Non–Small-Cell Lung Cancer and Programmed Death Ligand-1 Tumor Proportion Score ≥ 1% in the KEYNOTE-042 Study
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摘要Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co‐primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report 5-year results from the phase III KEYNOTE-042 study (ClinicalTrials.gov identifier: NCT02220894). Eligible patients with locally advanced/metastatic non–small-cell lung cancer (NSCLC) without EGFR/ALK alterations and with programmed death ligand-1 (PD-L1) tumor proportion score (TPS) ≥ 1\% received pembrolizumab 200 mg once every 3 weeks for 35 cycles or chemotherapy (carboplatin + paclitaxel or pemetrexed) for 4-6 cycles with optional maintenance pemetrexed. Primary end points were overall survival (OS) in PD-L1 TPS ≥ 50\%, ≥ 20\%, and ≥ 1\% groups. Patients who completed 35 cycles of pembrolizumab with ≥ stable disease could begin second-course pembrolizumab upon progression. One thousand two hundred seventy‐four patients were randomly assigned (pembrolizumab, n = 637; chemotherapy, n = 637). Median follow-up time was 61.1 (range, 50.0-76.3) months. OS outcomes favored pembrolizumab (v chemotherapy) regardless of PD-L1 TPS (hazard ratio [95\% CI] for TPS ≥ 50\%, 0.68 [0.57 to 0.81]; TPS ≥ 20\%, 0.75 [0.64 to 0.87]; TPS ≥ 1\%, 0.79 [0.70 to 0.89]), with estimated 5-year OS rates with pembrolizumab of 21.9\%, 19.4\%, and 16.6\%, respectively. No new toxicities were identified. Objective response rate was 84.3\% among 102 patients who completed 35 cycles of pembrolizumab and 15.2\% among 33 patients who received second-course pembrolizumab. First-line pembrolizumab monotherapy continued to show durable clinical benefit versus chemotherapy after 5 years of follow-up in PD-L1–positive, locally advanced/metastatic NSCLC without EGFR/ALK alterations and remains a standard of care.
出版社接受日期15.08.2022
著者Castro Gilberto, Kudaba Iveta, Wu Yi-Long, Lopes Gilberto, Kowalski DariuszM., Turna HandeZ., Caglevic Christian, Zhang Li, Karaszewska Boguslawa, Laktionov KonstantinK., Srimuninnimit Vichien, Bondarenko Igor, Kubota Kaoru, Mukherjee Rinee, Lin Jianxin, Souza Fabricio, Mok TonyS.K., Cho ByoungChul
期刊名稱Journal of Clinical Oncology
詳細描述PMID: 36306479
出版年份2022
國際標準期刊號0732-183X
語言美式英語
