First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer

作者：Xiaotian Zhang, Jufeng Wang, Gang Wang, Yanqiao Zhang, Qingxia Fan, Chuangxin Lu, Changlu Hu, Meili Sun, Yiye Wan, Sanyuan Sun, Junye Wang, Li Zhang, Yongqian Shu, Jie Luo, Dan Zhu, Zhenwei Shen, Sheng Yao, Qingmei Shi, Jason Yang, Lin Shen, GEMSTONE-303 Investigators, Yanru Xie, Xiaoyan Lin, Jiayi Li, Yunpeng Liu, Ruixing Zhang, Xiao Li, Ping Chen, Xinhui Yang, Zishu Wang, Zhanxiong Luo, Qi Li, Yanrong Gao, Qi Wang, Jianping Xiong, Ting Fu, Yan Lin, Zhong Xie, Yunbo Zhao, Yiping Mou, Tao Zhang, Wangjun Liao, Yinping Sun, Dong Yan, Yanxia Ji, Hongxia Li, Yongquan Shi, Hongming Pan, Yanhong Deng, Yanhua Chen, Juntao Yao, Anji Hou, Xinjun Liang · 发表于：JAMA · 年份：2025 · DOI：10.1001/jama.2024.28463 · 被引用次数：70 · 研究领域：Gastric Cancer Management and Outcomes、Cancer Immunotherapy and Biomarkers、Head and Neck Cancer Studies

Importance: Gastric cancer, including gastroesophageal junction cancer, is one of the most commonly diagnosed cancers worldwide, with high mortality. Sugemalimab is a fully human anti-programmed death-ligand 1 (PD-L1) antibody. The combination of sugemalimab and chemotherapy showed promising antitumor activity and safety in a phase 1b study among patients with treatment-naive, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. This combination was further evaluated in the GEMSTONE-303 phase 3 trial. Objective: To evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 combined positive score (CPS) of 5 or greater. Design, Setting, and Participants: GEMSTONE 303 is a phase 3, randomized, double-blind, placebo-controlled study conducted at 54 sites in China that enrolled patients from April 9, 2019, through December 29, 2021, with follow-up to July 9, 2023. A total of 479 eligible patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS of 5 or greater who did not receive any prior systemic therapy were randomized. Intervention: Patients received sugemalimab (1200 mg intravenously) (n = 241) or placebo (n = 238) every 3 weeks for up to 24 months, pl...