First-line nivolumab plus chemotherapy vs chemotherapy in patients with advanced gastric,gastroesophageal junction and esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis |
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| Authors: | Tianshu Liu Yuxian Bai Xiaoyan Lin Wei Li Jufeng Wang Xiaochun Zhang Hongming Pan Chunmei Bai Li Bai Ying Cheng Jingdong Zhang Haijun Zhong Yi Ba Wenwei Hu Ruihua Xu Weijian Guo Shukui Qin Nong Yang Jianwei Lu Kohei Shitara Ming Lei Mingshun Li Nicole Bao Tian Chen Lin Shen |
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| Affiliation: | 1. Zhongshan Hospital Fudan University, Shanghai, China;2. Herbin Medical University, Heilongjiang, China;3. Fujian Medical University Union Hospital, Fuzhou, China;4. The First Hospital of Jilin University, Changchun, China;5. The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China;6. The Affiliated Hospital of Qingdao University, Qingdao, China;7. Sir Run Run Shaw Hospital, Hangzhou, China;8. Peking Union Medical College Hospital, Beijing, China;9. China P.L.A. General Hospital (301 Hospital), Beijing, China;10. Jilin Cancer Hospital, Changchun, China;11. Liaoning Cancer Hospital and Institute, Shenyang, China;12. Zhejiang Cancer Hospital, Hangzhou, China;13. Tianjin Medical University Cancer Institute and Hospital, Tianjin, China;14. The First People's Hospital of Changzhou, Changzhou, China;15. Medical Oncology Cancer Center, Sun Yat-Sen University, Guangzhou, China;16. Fudan University Shanghai Cancer Center, Shanghai, China;17. Eastern Theater General Hospital, QinHuai District Medical Area, China;18. Hunan Cancer Hospital, Changsha Shi, China;19. Jiangsu Cancer Hospital, Nanjing, China;20. National Cancer Center Hospital East, Kashiwa, Japan;21. Bristol Myers Squibb, Princeton, New Jersey, USA;22. Department of Gastrointestinal Oncology Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China |
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| Abstract: | First-line chemotherapy for advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric/gastroesophageal junction cancer (GC/GEJC) has poor median overall survival (OS; <1 year). We report efficacy and safety results from Chinese patients in the phase III global CheckMate 649 study of nivolumab plus chemotherapy vs chemotherapy for the first-line treatment of GC/GEJC/esophageal adenocarcinoma (EAC). Chinese patients with previously untreated advanced or metastatic GC/GEJC/EAC were randomized to receive nivolumab (360 mg Q3W or 240 mg Q2W) plus chemotherapy (XELOX capecitabine and oxaliplatin] Q3W or FOLFOX oxaliplatin, leucovorin and 5-fluorouracil] Q2W), nivolumab plus ipilimumab (not reported) or chemotherapy alone. OS, blinded independent central review-assessed progression-free survival (PFS), objective response rate (ORR), duration of response (DOR) and safety are reported. Of 1581 patients enrolled and randomized, 208 were Chinese. In these patients, nivolumab plus chemotherapy resulted in clinically meaningful improvement in median OS (14.3 vs 10.2 months; HR 0.61 95% CI: 0.44-0.85]), median PFS (8.3 vs 5.6 months; HR 0.57 95% CI: 0.40-0.80]), ORR (66% vs 45%) and median DOR (12.2 vs 5.6 months) vs chemotherapy, respectively. The safety profile was acceptable, with no new safety signals observed. Consistent with results from the global primary analysis of CheckMate 649, nivolumab plus chemotherapy demonstrated a clinically meaningful improvement in OS and PFS and higher response rate vs chemotherapy and an acceptable safety profile in Chinese patients. Nivolumab plus chemotherapy represents a new standard first-line treatment for Chinese patients with non-HER2-positive advanced GC/GEJC/EAC. |
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| Keywords: | Asian Continental Ancestry Group gastrointestinal neoplasms immunotherapy nivolumab stomach neoplasms |
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