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作者

Xinan Sheng, Gongqian Zeng, Cuijian Zhang, Qingyun Zhang, Jiasheng Bian, Haitao Niu, Jun Li, Yanxia Shi, Kai Yao, Bin Hu, Ziling Liu, Hong Liao, Zhixian Yu, Baiye Jin, Peng Zhao, Tiejun Yang, Xianling Liu, Yang Qin, Xueyi Xue, Xin Gou, Jian Huang, Jiang Gu, Xiaolong Qi, Lu Zhang, Guoxian Ma, Beisong Liu, Jianmin Fang, Shusuan Jiang, Zhisong He, Aiping Zhou, Jun Guo  RC48-C016 Trial Investigators

作者单位

Affiliations ¹ Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Genitourinary Oncology, Peking University Cancer Hospital and Institute, Beijing. ² Hunan Cancer Hospital, Changsha, China. ³ Peking University First Hospital, Beijing. ⁴ Affiliated Cancer Hospital of Guangxi Medical University, Nanning, China. ⁵ Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China. ⁶ Affiliated Hospital of Qingdao University, Qingdao, China. ⁷ Chongqing University Cancer Hospital, Chongqing, China. ⁸ Sun Yat-sen University Cancer Center, Guangzhou, China. ⁹ Liaoning Cancer Hospital and Institute, Shenyang, China. ¹⁰ First Hospital of Jilin University, Changchun, China. ¹¹ Sichuan Cancer Hospital, Chengdu, China. ¹² First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. ¹³ First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. ¹⁴ Affiliated Cancer Hospital of Zhengzhou University-Henan Cancer Hospital, Zhengzhou, China. ¹⁵ Second Xiangya Hospital of Central South University, Changsha, China. ¹⁶ Yunnan Cancer Hospital, Kunming, China. ¹⁷ First Affiliated Hospital of Fujian Medical University, Fuzhou, China. ¹⁸ First Affiliated Hospital of Chongqing Medical University, Chongqing, China. ¹⁹ Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. ²⁰ Affiliated Hospital of Guizhou Medical University, Guiyang, China. ²¹ Zhejiang Provincial People's Hospital, Hangzhou, China. ²² RemeGen, Yantai, China. ²³ School of Life Science and Technology, Tongji University, Shanghai. ²⁴ National Cancer Center, National Clinical Research Center for Cancer, and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing.

刊名

The New England journal of medicine

年份

2025

ISSN

1533-4406

摘要

Background: Human epidermal growth factor receptor 2 -directed antibody-drug conjugate monotherapy has shown preliminary clinical efficacy in patients with chemotherapy-refractory HER2-positive locally advanced or metastatic urothelial cancer. Previous data showed promising antitumor activity and safety of HER2-specific disitamab vedotin as monotherapy and when combined with programmed cell death protein 1 -directed immunotherapy in this cancer. Methods: In this phase 3, multicenter, open-label,...更多

Background: Human epidermal growth factor receptor 2 -directed antibody-drug conjugate monotherapy has shown preliminary clinical efficacy in patients with chemotherapy-refractory HER2-positive locally advanced or metastatic urothelial cancer. Previous data showed promising antitumor activity and safety of HER2-specific disitamab vedotin as monotherapy and when combined with programmed cell death protein 1 -directed immunotherapy in this cancer. Methods: In this phase 3, multicenter, open-label, randomized trial, we assigned patients with previously untreated HER2-expressing locally advanced or metastatic urothelial cancer in a 1:1 ratio to receive either disitamab vedotin plus PD-1-specific toripalimab every 2 weeks or chemotherapy every 3 weeks. The dual primary end points were progression-free survival and overall survival. Secondary end points included objective response and safety. Here we report the prespecified progression-free survival analysis and interim overall survival analysis. Results: A total of 484 patients underwent randomization. The median follow-up was 18.2 months. Progression-free survival was significantly longer in the disitamab vedotin-toripalimab group than in the chemotherapy group . Overall survival was also significantly longer in the disitamab vedotin-toripalimab group than in the chemotherapy group . The percentage of patients with an objective response was 76.1% in the disitamab vedotin-toripalimab group and 50.2% in the chemotherapy group. The safety profile of disitamab vedotin plus toripalimab was more favorable than that of chemotherapy; grade 3 or higher treatment-related adverse events occurred in 55.1% of patients who received disitamab vedotin plus toripalimab and 86.9% of those who received chemotherapy. Conclusions: Disitamab vedotin-toripalimab led to a significantly greater improvement in outcomes than chemotherapy among patients with untreated HER2-expressing locally advanced or metastatic urothelial cancer. .收起

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