Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study

作者：Lingfang Xia, Jing Wang, Chunyan Wang, Qingming Zhang, Jianqing Zhu, Qunxian Rao, Huijun Cheng, Zheng Liu, Yongmei Yin, Xiaohong Ai, Kurban Gulina, Hong Zheng, Xiaoyong Luo, Baoping Chang, Li Li, Haiyan Liu, Yunxia Li, Ge Lou, Qi Zhou, Yanling Zhu, Zemin Xiao, Jiandong Tong, Ke Wang, Jie Chen, Xia Wang, Lijie Song, Zhixia Wei, Yijing Ye, Jiman Zhu, Xiaohua Wu · 发表于：International Journal of Gynecological Cancer · 年份：2023 · DOI：10.1136/ijgc-2023-004705 · 被引用次数：28 · 研究领域：Endometrial and Cervical Cancer Treatments、HER2/EGFR in Cancer Research、Colorectal and Anal Carcinomas

OBJECTIVE: There is an unmet need to improve clinical outcomes for patients with recurrent/metastatic cervical cancer. Checkpoint inhibitors represent a promising treatment strategy. We evaluated the safety and anti-tumor activity of zimberelimab, an anti-programmed cell death protein-1 antibody, in patients with previously treated, recurrent, metastatic cervical cancer. METHODS: This phase II, single-arm, open-label study used a Simon two-stage minimax design. Eligible patients were women aged 18-75 years with programmed death ligand-1-positive recurrent or metastatic cervical cancer that had progressed after first- or subsequent-line chemotherapy (Eastern Cooperative Oncology Group (ECOG) performance status 0-1). Patients received intravenous zimberelimab (240 mg every 2 weeks) for 2 years until disease progression, intolerable adverse effects, or withdrawal from the study. The primary endpoint was objective response rate assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, by an independent review committee. RESULTS: A total of 105 patients were enrolled. Median age was 51 (range, 31-75) years; 63.8% had an ECOG performance status of 1. The median number of previous treatment lines was 1 (range, 1-4). Median follow-up was 16.9 (range, 16.3-18.4) months. The objective response rate was 27.6%, and the disease control rate was 55.2%. Median duration of response was not reached. Median overall survival was 16.8 months, and median progression-free sur...