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357 GLS-010 (Zimberelimab), a novel fully human anti-PD-1 mAb in chinese patients with recurrent/metastatic cervical cancer: results from a multicenter, open-label, single-arm phase II trial
  1. X Wu1,
  2. L Xia1,
  3. Q Zhou2,
  4. J Zhu3,
  5. K Wang4,
  6. J Chen4,
  7. Y Huang5,
  8. G Kurb6,
  9. B Chang7,
  10. W Zhao8,
  11. X Wang9,
  12. Y Yang10,
  13. Z Lin11,
  14. X Luo12,
  15. G Lou13,
  16. C Wang14,
  17. J Wang15 and
  18. H Meng16
  1. 1Department of gynecologic oncology, Fudan University Shanghai Cancer Center, China
  2. 2Chongqing Cancer Hospital, China
  3. 3Zhejiang Cancer Hospital, China
  4. 4Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, China
  5. 5Hubei cancer hospital, China
  6. 6Cancer hospital affiliated to xinjiang medical university, China
  7. 7The First Affiliated Hospital of Henan University of Science and Technology, China
  8. 8The first affiliated hospital of university of science and technology of China, China
  9. 9The Affiliated Hospital of Xuzhou Medical University, China
  10. 10Guizhou Cancer Hospital, China
  11. 11Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China
  12. 12Luoyang Central Hospital, China
  13. 13Department of Gynecology Oncology, Harbin Medical University Cancer Hospital, China
  14. 14The 4th Department of Gynecology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, China
  15. 15Hunan Cancer Hospital, Changsha, China
  16. 16Guangzhou Gloria Biosciences Co., Ltd.,China


Introduction GLS-010 (Zimberelimab) is a novel fully human anti-PD-1 monoclonal antibody developed on the OMT transgenic rat platform, exhibiting good tolerance and pre-liminary efficacy in previous phase I study.

Methods In this open-label phase II clinical trial (NCT03972722), PD-L1 positive (combined positive score (CPS) ≥1) patients with recurrent or metastatic cervical cancer who had received one or more lines of chemotherapy were enrolled. All patients received GLS-010 240 mg every 2 weeks. Objective response was evaluated by RECIST v1.1. AEs were graded by NCI-CTCAE, version 4.03.

Results A total of 45 patients with recurrent or metastatic cervical cancer were enrolled. As of April 2, 2020, of 41 evaluable patients, 11 achieved an objective response by investigator assessment with an ORR of 26.83% and a DCR of 53.66%. After a median follow-up time of 5.2 months (range:1.6–9.7), 18 patients still remained on treatment and 27 of them discontinued treatment due to progressive disease or adverse events. The Median DOR had not been reached yet. 36 of 45 (80.00%) patients experienced one or more treatment-related adverse events(TRAE), most of which were Grade 1 or 2.≥Grade 3 TRAEs occurred in 17 (37.78%) patients, and the most common one was Anaemia. Only 1 patient discontinued treatment due to adverse event.

Conclusion GLS-010 (Zimberelimab) showed encouraging therapeutic activity and manageable safety profile in Chinese recurrent or metastatic cervical cancer patients. This study is still ongoing, and we are looking forward to further results.

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