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

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

JTO Clinical and Research Reports (Oct 2021)

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

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

Affiliations

Ying Cheng, MD: Department of Medical Oncology, Jilin Cancer Hospital, Changchun, People’s Republic of China; Corresponding author. Address for correspondence: Ying Cheng, MD, Department of Medical Oncology, Jilin Cancer Hospital, Number 1018, Huguang Road, Chaoyang Borough, Changchun 130012, People’s Republic of China.
Li Zhang, MD: Respiratory Medicine Department, Peking Union Medical College Hospital, Beijing, People’s Republic of China
Jie Hu, MD, PhD, FCCP: Department of Pulmonary Medicine, Zhongshan Hospital Fudan University, Shanghai, People’s Republic of China
Donglin Wang, MD: Department of Oncology, Chongqing Cancer Hospital, Chongqing, People’s Republic of China
ChengPing Hu, MD: Department of Respirology and Critical Care Medicine, Xiangya Hospital Central South University, Changsha, People’s Republic of China
Jianying Zhou, MD: Department of Respiratory Diseases, The First Affiliated Hospital of Zhejiang University, Hangzhou, People’s Republic of China
Lin Wu, MD: Department of Thoracic Medicine, Hunan Cancer Hospital, Changsha, People’s Republic of China
Lejie Cao, MD: Department of Respiration, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, People’s Republic of China
Jiwei Liu, MD: Department of Oncology, The First Affiliated Hospital of Dalian Medical University, Dalian, People’s Republic of China
Helong Zhang, MD: Department of Oncology, Tang Du Hospital, The Fourth Military Medical University, Xi'an, People’s Republic of China
Hong Sun, MD: Department of Oncology, The First Affiliated Hospital of Xi’An Jiaotong University, Xi'an, People’s Republic of China
Ziping Wang, PhD: Department of Thoracic Medical Oncology, Beijing Cancer Hospital, Beijing, People’s Republic of China
Hongjun Gao, MD: Department of Pulmonary Oncology, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, People’s Republic of China
Yuping Sun, MD: MSD China, Shanghai, People’s Republic of China
Ben Li, PhD: MSD China, Beijing, People’s Republic of China
Xiaohan Hu, PhD, MPH: Merck & Co., Inc., Kenilworth, New Jersey
Paul Schwarzenberger, MD: Merck & Co., Inc., Kenilworth, New Jersey
Luis Paz-Ares, MD, PhD: Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain

Journal volume & issue: Vol. 2, no. 10
p. 100225

Abstract

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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.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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