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.