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ePoster Display

1439TiP - A randomized, double-blinded, placebo-controlled phase III trial of HX008 plus irinotecan as second-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Site

Gastric Cancer

Presenters

Jing Huang

Citation

Annals of Oncology (2021) 32 (suppl_5): S1040-S1075. 10.1016/annonc/annonc708

Authors

J. Huang1, S. Luo2, P. Chen3, Y. Pan4, Z. Zhuang5, B. Liu6, Y. Ling7, J. Zhang8, Q. Fan9, H. Wang10, R. Lin11, H. Zhong12, Z. Chen13, S. Li14, J. Lv15, B. Cao16, L. Zhao17, Y. Yang18, J. Tong19, S. Cang20

Author affiliations

  • 1 Department Of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 2 Department Of Medical Oncology, Henan Cancer Hospital, the Affiliated Cancer Hospital of Zhengzhou University, 450008 - Zhengzhou/CN
  • 3 Department Of Medical Oncology, General Hospital of Ningxia Medical University, 750001 - Ningxia/CN
  • 4 Department Of Medical Oncology, Anhui Provincial Hospital, 230001 - Hefei/CN
  • 5 Oncology Department, The Second Affiliated Hospital of Soochow University, 215000 - Suzhou/CN
  • 6 Department Of Medical Oncology, Shandong Cancer Hospital, 250117 - Jinan/CN
  • 7 Oncology Department, Changzhou Cancer Hospital, Changzhou/CN
  • 8 Department Of Medical Oncology, Liaoning Cancer Hospital & Institute, Shenyang/CN
  • 9 Oncology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou/CN
  • 10 Department Of Medical Oncology, Gansu Wuwei Tumor Hospital, Wuwei/CN
  • 11 Oncology Department, Fujian Cancer Hospital, 350000 - Xiamen/CN
  • 12 Department Of Medical Oncology, Zhejiang Cancer Hospital, 310022 - Hangzhou/CN
  • 13 Department Of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei/CN
  • 14 Department Of Medical Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang/CN
  • 15 Department Of Medical Oncology, The Affiliated Hospital of Qingdao University, Qingdao/CN
  • 16 Oncology Department, Beijing Friendship Hospital,Capital Medical University, Beijing/CN
  • 17 Department Of Medical Oncology, Peking Union Medical College Hospital, Beijing/CN
  • 18 Oncology Department, Nanjing Drum Tower Hospital, Nanjing/CN
  • 19 Oncology Department, Yangzhou First People's Hospital, Yangzhou/CN
  • 20 Department Of Medical Oncology, Henan Provincial People's Hospital, Zhengzhou/CN

Resources

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Abstract 1439TiP

Background

Standard second-line therapy for patients with recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) cancer includes taxane or irinotecan monotherapy, ramucirumab alone or in combination with paclitaxel. HX008 is a novel highly selective, fully humanized anti-PD-1 monoclonal antibody with an engineered Fc domain. Previous report of HX008 plus irinotecan has demonstrated promising efficacy and manageable safety profile in patients with advanced G/GEJ adenocarcinoma. A phase III trial has been conducted to evaluate the efficacy and safety of HX008 plus irinotecan versus placebo plus irinotecan as second-line treatment in patients advanced G/GEJ adenocarcinoma.

Trial design

Key patient eligibility criteria are histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma, has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy, measurable or non-measurable evaluable disease per RECIST v1.1, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients will be randomly assigned 1:1 to HX008 or placebo plus irinotecan. Randomization will be stratified by ECOG performance status (0 vs 1), PD-L1 tumor expression status (combined positive score < 1 vs ≥ 1), time to progression on firstline therapy (<6 months vs ≥ 6 months). HX008 200 mg or placebo will be administered intravenously (IV) every 3 weeks (Q3W), and irinotecan 160 mg/m2 will be administered intravenously (IV) every 2 weeks (Q2W). Patients will continue to receive treatment until disease progression, unaccepted toxicity, physician decision or patient withdrawal of consent, whichever comes first. The primary endpoint is overall survival in all patients and patients with PD-L1 CPS ≥ 1. Secondary endpoints include progression free survival, objective response rate, disease control rate and duration of response per RECIST v1.1 as assessed by investigators as well as safety and tolerability. This trial is currently enrolling.

Clinical trial identification

NCT04486651.

Editorial acknowledgement

Legal entity responsible for the study

Taizhou Hanzhong Biomedical Co., Ltd.

Funding

Taizhou Hanzhong Biomedical Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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