Pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced non–small cell lung cancer without tumor PD‐L1 expression: A pooled analysis of 3 randomized controlled trials

作者：Hossein Borghaei, Corey Jay Langer, Luis G Paz-Ares, Delvys Rodríguez‐Abreu, Balázs Halmos, Marina Chiara Garassino, Baerin Houghton, Takayasu Kurata, Ying Cheng, Jianxin Lin, Maria Catherine Pietanza, Bilal Piperdi, Shirish M. Gadgeel · 发表于：Cancer · 年份：2020 · DOI：10.1002/cncr.33142 · 被引用次数：113 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Diagnosis and Treatment、Lung Cancer Treatments and Mutations

BACKGROUND: Pembrolizumab plus platinum-based chemotherapy has demonstrated improved clinical outcomes over chemotherapy alone in patients with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. This study pooled data from 3 randomized controlled trials to evaluate outcomes with pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced/metastatic NSCLC negative for PD-L1 (ie, a tumor proportion score < 1%). METHODS: Individual patient data were pooled from KEYNOTE-021 cohort G (nonsquamous; NCT02039674), KEYNOTE-189 (nonsquamous; NCT02578680 and NCT03950674), and KEYNOTE-407 (squamous; NCT02775435). Treatment comprised pembrolizumab plus chemotherapy (pemetrexed and platinum for nonsquamous histology and carboplatin and paclitaxel/nab-paclitaxel for squamous histology) or chemotherapy alone. Responses were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 by blinded, independent, central review. No α was assigned to this descriptive, exploratory analysis. RESULTS: Four hundred forty-four of the 1328 patients (33.4%) who were enrolled across the 3 trials had PD-L1-negative tumors (256 on pembrolizumab plus chemotherapy [nonsquamous, n = 155; squamous, n = 94; other, n = 7] and 188 on chemotherapy alone [nonsquamous, n = 83; squamous, n = 99; other, n = 6]). The median time from randomization to the data cutoff was 28.0 months (range...