Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial |
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| Authors: | Yi-Long Wu Shun Lu Ying Cheng Caicun Zhou Jie Wang Tony Mok Li Zhang Hai-Yan Tu Lin Wu Jifeng Feng Yiping Zhang Alexander Valerievich Luft Jianying Zhou Zhiyong Ma You Lu Chengping Hu Yuankai Shi Christine Baudelet Jianhua Chang |
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| Institution: | 1. Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China;2. Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China;3. Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China;4. Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China;5. 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;6. Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong SAR, China;7. Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China;8. Department II of Thoracic Medicine, Hunan Cancer Hospital, Changsha, China;9. Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China;10. Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China;11. Department of Oncology No 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St. Petersburg, Russia;12. Department of Respiratory Diseases, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China;13. Department of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China;14. Department of Thoracic Oncology, West China Hospital, Chengdu, China;15. Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China;p. Department of Statistics, Bristol-Myers Squibb, Lawrence Township, New Jersey;q. Department of Immuno-oncology, Bristol-Myers Squibb, Lawrence Township, New Jersey;r. Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China |
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| Abstract: | IntroductionData 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.MethodsCheckMate 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/m 2 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. ResultsOS 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.ConclusionsThis 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. |
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| Keywords: | Chinese population Nivolumab NSCLC Phase III clinical study |
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