Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study
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Published:2023-10-24
Issue:12
Volume:33
Page:1861-1868
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ISSN:1048-891X
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Container-title:International Journal of Gynecologic Cancer
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language:en
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Short-container-title:Int J Gynecol Cancer
Author:
Xia Lingfang, Wang Jing, Wang Chunyan, Zhang Qingming, Zhu JianqingORCID, Rao Qunxian, Cheng Huijun, Liu Zheng, Yin Yongmei, Ai Xiaohong, Gulina Kurban, Zheng Hong, Luo Xiaoyong, Chang Baoping, Li Li, Liu Haiyan, Li Yunxia, Lou Ge, Zhou QiORCID, Zhu Yanling, Xiao Zemin, Tong Jiandong, Wang Ke, Chen Jie, Wang Xia, Song Lijie, Wei Zhixia, Ye Yijing, Zhu Jiman, Wu XiaohuaORCID
Abstract
ObjectiveThere 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.MethodsThis 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.ResultsA 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 survival was 3.7 months. The incidence of treatment-related adverse events of any grade was 78.1%, of which the most common were hypothyroidism (26.7%) and anemia (19.0%).ConclusionZimberelimab monotherapy demonstrated durable anti-tumor activity and an acceptable safety profile in patients with cervical cancer.Clinical trial registrationNCT03972722.
Funder
Guangzhou Gloria Biosciences Co., Ltd.
Subject
Obstetrics and Gynecology,Oncology
Reference15 articles.
1. World Health Organization . Cervical cancer fact sheet 2022. 2023. Available: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer 2. World Health Organization . China fact sheet: Globocan 2020. 2022. Available: https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf 3. National Comprehensive Cancer Network (NCCN) . NCCN clinical practice guidelines in oncology: cervical cancer. 2022. Available: https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf 4. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study 5. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer
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