Abstract

The prognosis of patients with advanced non small cell lung (NSCLC) cancer remains dismal. Epidermal Growth Factor Receptor is over-expressed in many epithelial derived tumors and its role in the development and progression of NSCLC is widely documented. CimaVax-EGF is a therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor (EGF) conjugated to a carrier protein, P64K from Neisseria Meningitides. The vaccine is intended to induce antibodies against self EGF that would block EGF-EGFR interaction. CimaVax-EGF has been evaluated so far in more than 1000 advanced NSCLC patients, as second line therapy. Two separate studies were compared to assess the impact of high dose vaccination at multiple anatomic sites in terms of immunogenicity, safety and preliminary efficacy in stage IIIb/IV NSCLC patients. In both clinical trials, patients started vaccination 1 month after finishing first line chemotherapy. Vaccination at 4 sites with 2.4 mg of EGF (high dose) was very safe. The most frequent adverse events were grade 1 or 2 injection site reactions, fever, headache and vomiting. Patients had a trend toward higher antibody response. The percent of very good responders significantly augmented and there was a faster decrease of circulating EGF. All vaccinated patients and those classified as good responders immunized with high dose at 4 sites, had a large tendency to improved survival.

Highlights

  • In spite of an intensive research effort, lung cancer is the leading cause of cancer death

  • Two separate studies were compared to assess the impact of high dose vaccination at multiple anatomic sites in terms of immunogenicity, safety and preliminary efficacy of CimaVax-Epidermal Growth Factor (EGF) in advanced non-small-cell lung cancer (NSCLC) patients

  • The antibodies elicited by vaccination provoke an immune-castration of EGF, which hampers EGF-Epidermal Growth Factor Receptor (EGFR) interaction

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Summary

Introduction

In spite of an intensive research effort, lung cancer is the leading cause of cancer death. For advanced non-small-cell lung cancer (NSCLC), first-line platinum-based chemotherapy has reached a plateau of effectiveness [1]. For the second or third line therapy, the reported response rate is usually less than 10% and the median survival time rarely exceeds the 8 months boundary [2]. The Epidermal Growth Factor Receptor is a very well validated target in NSCLC and it is over-expressed in a very high percent of tumors classified as NSCLC [3]. Strategies to block this pathway include tyrosine kinase inhibitors (TKIs) and monoclonal antibodies [2,3]. 2 small inhibitors, are recommended as second

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