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673 Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase II study
  1. Xiaohua Wu1,
  2. Lingfang Xia1,
  3. Jing Wang2,
  4. Chunyan Wang3,
  5. Qingming Zhang4,
  6. Jianqing Zhu5,
  7. Qunxian Rao6,
  8. Huijun Cheng7,
  9. Zheng Liu8,
  10. Yongmei Yin9,
  11. Xiaohong Ai10,
  12. Kurban Gulina11,
  13. Hong Zheng12,
  14. Xiaoyong Luo13,
  15. Baoping Chang14,
  16. Li Li15,
  17. Haiyan Liu16,
  18. Yunxia Li17,
  19. Ge Lou18,
  20. Qi Zhou19,
  21. Yanling Zhu20,
  22. Zemin Xiao21,
  23. Jiandong Tong22,
  24. Ke Wang23,
  25. Jie Chen23,
  26. Xia Wang24,
  27. Lijie Song25,
  28. Zhixia Wei26,
  29. Yijing Ye27 and
  30. Jiman Zhu28
  1. 1Fudan University Shanghai Cancer Center, Shanghai, China
  2. 2Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China
  3. 3Liaoning Cancer Hospital and Institute, Shenyang, China
  4. 4Gansu Provincial Cancer Hospital, Gansu Provincial Academic Institute for Medical Research, Lanzhou, China
  5. 5Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China
  6. 6Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
  7. 7Henan Cancer Hospital, Zhengzhou, China
  8. 8Handan Central Hospital, Handan, China
  9. 9The First Affiliated Hospital of Nanjing Medical University, Nanjing, China
  10. 10The First Affiliated Hospital Of University Of South China, Hengyang, China
  11. 11The Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China
  12. 12Beijing Cancer Hospital, Beijing, China
  13. 13The Affiliated Luoyang Central Hospital of Zhengzhou University, Luoyang, China
  14. 14The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China
  15. 15Guangxi Medical University Affiliated Tumor Hospital, Nanning, China
  16. 16The Second Affiliated Hospital of Shandong First Medical University, Taian, China
  17. 17General Hospital of Ningxia Medical University, Yinchuan, Yinchuan, China
  18. 18Harbin Medical University Cancer Hospital, Harbin, China
  19. 19Chongqing University Cancer Hospital, Chongqing, China
  20. 20Xuzhou Tumor Hospital, Xuzhou, China
  21. 21The First People’s Hospital of Changde City, Changde, China
  22. 22Affiliated Hospital of Yangzhou University, Yangzhou, China
  23. 23Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
  24. 24The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
  25. 25The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
  26. 26Hainan Cancer Hospital, Haikou, China
  27. 27Zhongshan City People’s Hospital, Zhongshan, China
  28. 28Guangzhou Gloria Biosciences Co., Ltd., Beijing, China


Background Cervical cancer is the fourth most common cancer affecting women globally, but treatment options and outcomes for patients with recurrent or metastatic disease remain limited. Zimberelimab is a novel, fully human anti-PD-1 monoclonal antibody with high affinity and selectivity for PD-1. The objective of this study ( identifier: NCT03972722) was to evaluate zimberelimab, a novel, anti-programmed cell death protein 1 monoclonal antibody, in patients with programmed death ligand-1-positive recurrent or metastatic cervical cancer that had progressed after first- or subsequent-line platinum-containing standard chemotherapy.

Methods In this single-arm, phase II study, eligible patients in 27 Chinese sites were assigned to receive intravenous zimberelimab 240 mg as monotherapy every 2 weeks until confirmed disease progression, death, intolerable adverse effects, or withdrawal from the study. The primary endpoint was the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors (version 1.1) by an independent review committee. Secondary endpoints included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results Ninety participants were included in the full analysis set, with a median follow-up of 11.5 months. Complete and partial responses were achieved by 4 and 21 patients, respectively, corresponding to an ORR of 27.8% (95% confidence interval [CI], 18.85 to 38.22; P < .0001 vs historical controls). Median OS and DoR were not reached during the study: 12-month OS rates were 54% (95% CI, 41 to 66) and 6-month DoR rates were 84% (95% CI, 58 to 95). Median PFS was 3.7 months and the 12-month PFS rate was 15% (95% CI, 2 to 42). Treatment-related adverse events (TRAEs) occurred in 78.1% of participants, with hypothyroidism (25.7%) and anemia (19.0%) being the most frequently reported. Grade ≥ 3 TRAEs occurred in 22.9% of participants.

Conclusions Zimberelimab monotherapy demonstrated durable antitumor activity and an acceptable safety profile in patients with recurrent or metastatic cervical cancer that had progressed after first- or subsequent-line platinum-containing standard chemotherapy. Further investigation of zimberelimab in patients with cervical cancer is warranted.

Trial Registration NCT03972722

Ethics Approval This phase II, single-arm, open-label study (NCT03972722) enrolled patients at 27 sites in China. The study was approved by the ethics committee at each participating center and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice for Drug Trials. All participants provided signed informed consent before any study procedure.

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