Shun Lu1, Jie Wang2, Ying Cheng3, Tony Mok4, Jianhua Chang5, Li Zhang6, Jifeng Feng7, Hai-Yan Tu8, Lin Wu9, Yiping Zhang10, Alexander Luft11, Jian-Ying Zhou12, Zhiyong Ma13, You Lu14, Chengping Hu15, Yuankai Shi16, Kejing Ying17, Hua Zhong18, Elena Poddubskaya19, Ross A Soo20, Yee Hong Chia21, Ang Li22, Amy Li23, Yi-Long Wu24. 1. Shanghai Chest Hospital, 241 Huaihai West Road, Shanghai, 200030, China. Electronic address: shun_lu@hotmail.com. 2. Cancer Hospital Chinese Academy of Medical Sciences, 17 Nanli Panjiayuan, Beijing, 100021, China. Electronic address: zlhuxi@163.com. 3. Jilin Cancer Hospital, 1018 Huguang Road, Changchun, Jilin, 130012, China. Electronic address: jl.cheng@163.com. 4. State Laboratory of Translational Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, 30-32 Ngan Shing Street, Hong Kong, China. Electronic address: tony@clo.cuhk.edu.hk. 5. Fudan University Shanghai Cancer Center, 270 Dongan Road, Shanghai, 200032, China. Electronic address: changjianhua@163.com. 6. Sun Yat-Sen University Cancer Center, 651 Dong Feng East Road, Guangzhou, Guangdong, 510060, China. Electronic address: zhangli@sysucc.org.cn. 7. Jiangsu Cancer Hospital, 42 Bai Zi Ting, Nanjing, Jiangsu, 210000, China. Electronic address: fjif@vip.sina.com. 8. Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan Second Road, Guangzhou 510080, China. Electronic address: thy0934789@163.com. 9. Hunan Cancer Hospital, 283 Tongzipo Road, Changsha, Hunan, 410013, China. Electronic address: wulin-calf@vip.163.com. 10. Zhejiang Cancer Hospital, 1 Banshan East Road, Hangzhou, Zhejiang, 310022, China. Electronic address: zyp352@163.com. 11. Leningrad Regional Clinical Hospital, 45-49 Lunacharskogo Avenue, St. Petersburg, 194291, Russian Federation. Electronic address: alexander_luft@mail.ru. 12. The 1st Affiliated Hospital of College of Medicine, 79 Qingchun Road, Hangzhou, Zhejiang, 310003, China. Electronic address: drzjy@163.com. 13. The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, 127 Dongming Road, Zhengzhou, Henan, 450008, China. Electronic address: 18638529152@163.com. 14. West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, China. Electronic address: radyoulu@hotmail.com. 15. Xiangya Hospital of Central South University, 87 Xiangya Road, Changsha, Hunan, 410008, China. Electronic address: huchengp28@csu.edu.cn. 16. Cancer Hospital Chinese Academy of Medical Sciences, 17 Nanli Panjiayuan, Beijing, 100021, China. Electronic address: syuankai@cicams.ac.cn. 17. Sir Run Run Shaw Hospital, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, China. Electronic address: yingsrrsh@163.com. 18. Shanghai Chest Hospital, 241 Huaihai West Road, Shanghai, 200030, China. Electronic address: eddiedong8@hotmail.com. 19. Clinical Center VitaMed, 10 Seslavinskaya Str, Moscow, Russian Federation. Electronic address: podd-elena@yandex.ru. 20. National University Hospital, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ross_soo@nuhs.edu.sg. 21. Johns Hopkins Singapore Pte Ltd, 11 Jalan Tan Tock Seng, 308433, Singapore. Electronic address: yee_hong_chia@ttsh.com.sg. 22. Bristol Myers Squibb, Princeton, NJ, 08540, USA. Electronic address: angus.lee@bms.com. 23. Bristol Myers Squibb, Princeton, NJ, 08540, USA. Electronic address: amy.Li1@bms.com. 24. Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan Second Road, Guangzhou 510080, China. Electronic address: syylyu@live.cn.
Abstract
BACKGROUND: In the phase 3 CheckMate 078 study, nivolumab showed significant overall survival (OS) benefit and superior tolerability versus docetaxel in a predominantly Chinese patient population with non-small cell lung cancer (NSCLC). However, data on long-term outcomes with immunotherapy in Asian patients are limited. We report 2-year efficacy and safety data. METHODS:Patients with advanced/metastatic NSCLC and disease progression after platinum-doublet chemotherapy were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks; n = 338) or docetaxel (75 mg/m2 every 3 weeks; n = 166) until progression, unacceptable toxicity, or other protocol-defined reasons. The primary endpoint was OS; secondary endpoints included progression-free survival, objective response rate, and safety. RESULTS: After 25.9 months minimum follow-up, 21 patients (6 %) remained on nivolumab versus 0 on docetaxel. Median OS was 11.9 months with nivolumab versus 9.5 months with docetaxel (HR: 0.75; 95 % CI: 0.61-0.93); 2-year OS rates were 28 % versus 18 %, respectively. Survival benefits were observed across a variety of predefined subgroups. At 2 years, 39 % and 0 % of responders had ongoing responses with nivolumab and docetaxel, respectively. Grade 3-4 treatment-related adverse events occurred in 12 % of patients with nivolumab versus 47 % with docetaxel, leading to discontinuation in 4 % and 5 % of patients, respectively. No new treatment-related deaths occurred. CONCLUSION: At 2 years, nivolumab maintained a favorable safety profile and continued to demonstrate superior OS versus docetaxel in this predominantly Chinese patient population with previously treated NSCLC. These data are consistent with long-term outcomes from the global CheckMate 017/057 studies.
RCT Entities:
BACKGROUND: In the phase 3 CheckMate 078 study, nivolumab showed significant overall survival (OS) benefit and superior tolerability versus docetaxel in a predominantly Chinese patient population with non-small cell lung cancer (NSCLC). However, data on long-term outcomes with immunotherapy in Asian patients are limited. We report 2-year efficacy and safety data. METHODS:Patients with advanced/metastatic NSCLC and disease progression after platinum-doublet chemotherapy were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks; n = 338) or docetaxel (75 mg/m2 every 3 weeks; n = 166) until progression, unacceptable toxicity, or other protocol-defined reasons. The primary endpoint was OS; secondary endpoints included progression-free survival, objective response rate, and safety. RESULTS: After 25.9 months minimum follow-up, 21 patients (6 %) remained on nivolumab versus 0 on docetaxel. Median OS was 11.9 months with nivolumab versus 9.5 months with docetaxel (HR: 0.75; 95 % CI: 0.61-0.93); 2-year OS rates were 28 % versus 18 %, respectively. Survival benefits were observed across a variety of predefined subgroups. At 2 years, 39 % and 0 % of responders had ongoing responses with nivolumab and docetaxel, respectively. Grade 3-4 treatment-related adverse events occurred in 12 % of patients with nivolumab versus 47 % with docetaxel, leading to discontinuation in 4 % and 5 % of patients, respectively. No new treatment-related deaths occurred. CONCLUSION: At 2 years, nivolumab maintained a favorable safety profile and continued to demonstrate superior OS versus docetaxel in this predominantly Chinese patient population with previously treated NSCLC. These data are consistent with long-term outcomes from the global CheckMate 017/057 studies.