Pembrolizumab Plus Chemotherapy for Chinese Patients With Metastatic Squamous NSCLC in KEYNOTE-407

• Main Authors: Ying Cheng, MD, Li Zhang, MD, Jie Hu, MD, PhD, FCCP, Donglin Wang, MD, ChengPing Hu, MD, Jianying Zhou, MD, Lin Wu, MD, Lejie Cao, MD, Jiwei Liu, MD, Helong Zhang, MD, Hong Sun, MD, Ziping Wang, PhD, Hongjun Gao, MD, Yuping Sun, MD, Ben Li, PhD, Xiaohan Hu, PhD, MPH, Paul Schwarzenberger, MD, Luis Paz-Ares, MD, PhD
• Format: Article
• Language: English
• Published: Elsevier 2021-10-01
• Series: JTO Clinical and Research Reports
• Subjects: Programmed death 1 blockade; Pembrolizumab; Chemotherapy; Squamous Non–small-cell lung cancer; China
• Online Access: http://www.sciencedirect.com/science/article/pii/S2666364321000849
• ISSN: 2666-3643

Introduction: Pembrolizumab plus chemotherapy significantly improved survival outcomes versus placebo plus chemotherapy in patients with previously untreated metastatic squamous NSCLC in the randomized, double-blind, phase 3 KEYNOTE-407 study. We present the results of Chinese patients enrolled in the KEYNOTE-407 global and China extension studies. Methods: Patients enrolled from mainland China in the KEYNOTE-407 global (NCT02775435) and China extension studies (NCT03875092) were randomized 1:1 to 35 cycles of pembrolizumab or placebo plus four cycles of carboplatin and paclitaxel or nab-paclitaxel. Dual primary end points were overall survival (OS) and progression-free survival (PFS) (based on the Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review). Results: A total of 125 patients were randomized (pembrolizumab–chemotherapy, n = 65; placebo–chemotherapy, n = 60). As of September 30, 2020, median (range) study follow-up was 28.1 (25.1‒40.9) months. Pembrolizumab–chemotherapy improved OS (hazard ratio [HR] = 0.44, 95% confidence interval [CI]: 0.28–0.70) and PFS (HR = 0.35, 95% CI: 0.24–0.52) versus placebo–chemotherapy. Two-year OS and PFS rates for pembrolizumab–chemotherapy versus placebo–chemotherapy were 56.9% versus 31.7% and 24.2% versus 3.3%, respectively. Treatment-related grade 3 to 5 adverse events occurred in 81.5% and 81.7%, respectively. Relative to baseline, pembrolizumab–chemotherapy improved global health status/quality of life scores at week 18 versus placebo–chemotherapy (difference in least squares means = 7.6, 95% CI: 1.5–13.7) and prolonged time to deterioration in cough, chest pain, or dyspnea (HR = 0.50, 95% CI: 0.28–0.89). Conclusions: Pembrolizumab–chemotherapy prolonged survival versus placebo–chemotherapy with manageable toxicity and preserved or improved health-related quality of life in Chinese patients with metastatic squamous NSCLC. These findings support pembrolizumab–chemotherapy as first-line therapy in this population.