Therapeutic cancer vaccine: Phase I clinical tolerance study of Hu-rhEGF-rP64k/Mont in patients with newly diagnosed advanced non-small cell lung cancer

Puyuan Xing, Hongyu Wang, Sheng Yang, Xiaohong Han, Yan Sun, Yuankai Shi

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: Hu-rhEGF-rP64k/Mont is a biotechnology product for the treatment of advanced non-small cell lung cancer (NSCLC). The vaccine induces a neutralizing antibody-mediated immune response, against the normal circulating self-protein antigen epidermal growth factor (EGF), which prevents its binding to and activation of the EGF receptor, inhibiting the transduction of the signals that drive cancer cell proliferation, survival and spread. This phase I study aimed to evaluate the safety and the immunological response of Hu-rhEGF-rP64k vaccine in NSCLC patients. Results: The Hu-rhEGF-rP64k/Mont vaccine showed to be safe and well tolerated, with dizziness, injection-site reactions and tremors being the most commonly reported adverse event. No severe adverse events or death were related to the vaccination. Immune monitoring demonstrated the generation of anti-EGF antibody titers and as a consequence the patients exhibited a decrease in the EGF concentration. In 80% of the vaccinated patients stable disease was achieved. Conclusion: Hu-rhEGF-rP64k/Mont elicited a valuable immune response, with good safety profile assuring further clinical development of the vaccine in this population to further confirm the potential benefits on survival.

Original languageEnglish
Article number14
JournalBMC Immunology
Volume19
Issue number1
DOIs
StatePublished - Apr 16 2018

Keywords

  • Cancer vaccine
  • Clinical study
  • Lung cancer

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