Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced Non-Small Cell Lung Cancer: CheckMate 078 Randomized Phase III Clinical Trial,Journal of Thoracic Oncology

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Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced Non-Small Cell Lung Cancer: CheckMate 078 Randomized Phase III Clinical Trial
Journal of Thoracic Oncology ( IF 21.0 ) Pub Date : 2019-05-01 , DOI: 10.1016/j.jtho.2019.01.006
Yi-Long Wu ₁ , Shun Lu ₂ , Ying Cheng ₃ , Caicun Zhou ₄ , Jie Wang ₅ , Tony Mok ₆ , Li Zhang ₇ , Hai-Yan Tu ₁ , Lin Wu ₈ , Jifeng Feng ₉ , Yiping Zhang ₁₀ , Alexander Valerievich Luft ₁₁ , Jianying Zhou ₁₂ , Zhiyong Ma ₁₃ , You Lu ₁₄ , Chengping Hu ₁₅ , Yuankai Shi ₅ , Christine Baudelet ₁₆ , Junliang Cai ₁₇ , Jianhua Chang ₁₈

Affiliation

Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.
Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China.
Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong SAR, China.
Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Department II of Thoracic Medicine, Hunan Cancer Hospital, Changsha, China.
Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.
Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Department of Oncology No 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St. Petersburg, Russia.
Department of Respiratory Diseases, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Department of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Department of Thoracic Oncology, West China Hospital, Chengdu, China.
Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China.
Department of Statistics, Bristol-Myers Squibb, Lawrence Township, New Jersey.
Department of Immuno-oncology, Bristol-Myers Squibb, Lawrence Township, New Jersey.
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.

Introduction: Data on immuno‐oncology agents in Chinese patients are limited despite a need for new therapies. We evaluated the efficacy and safety of nivolumab in a predominantly Chinese patient population with previously treated NSCLC. Methods: CheckMate 078 was a randomized, open‐label, phase III clinical trial in patients from China, Russia, and Singapore with squamous or nonsquamous NSCLC that had progressed during/after platinum‐based doublet chemotherapy (ClinicalTrials.gov: NCT02613507). Patients with EGFR/ALK alterations were excluded. Patients (N = 504) were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks), stratified by performance status, tumor histology, and tumor programmed death ligand 1 expression. The primary endpoint was overall survival (OS); secondary endpoints included objective response rate, progression‐free survival, and safety. Results: OS was significantly improved with nivolumab (n = 338) versus docetaxel (n = 166); median OS (95% confidence interval): 12.0 (10.4–14.0) versus 9.6 (7.6–11.2) months, respectively; hazard ratio (97.7% confidence interval): 0.68 (0.52–0.90); p = 0.0006. Objective response rate was 17% with nivolumab versus 4% with docetaxel; median duration of response was not reached versus 5.3 months. Minimum follow‐up was 8.8 months. The frequency of grade 3 or greater treatment‐related adverse events was 10% with nivolumab and 48% with docetaxel. Conclusions: This is the first phase III study in a predominantly Chinese population reporting results with a programmed death 1 inhibitor. In this population with previously treated advanced NSCLC, nivolumab improved OS versus docetaxel. Results were consistent with global CheckMate 017 and 057 studies.

更新日期：2019-05-01

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