Nimotuzumab and CIMAvax-EGF® in Advanced Cervical Cancer

Cervical cancer is the fourth cancer worldwide in the female sex in terms of incidence, becoming one of the most frequent epithelial tumors. The high overexpression of the Epidermal Growth Factor Receptor (EGFr) present in it offers the opportunity to use therapies against this receptor. A prospective, multicenter Expanded Access Program (EAP) was carried out in three randomized groups to demonstrate the safety and preliminary efficacy of humanized monoclonal antibody nimotuzumab, CIMAvax-EGF® vaccine and its combination in advanced cervical cancer, refractory to all previous oncospecific therapies. The principal endpoint was to assess overall survival time (the life expectancy of these patients at the inclusion was six months) and demonstrate the safety of those treatments. Overall survival was higher than expected in all groups. In general, 43.9% of patients were alive 2 years after the start of immunotherapy, and the 60-month survival rate was 38.8, 42.7, and 37.4% for CIMAvax-EGF®, Nimotuzumab, and combination therapies, respectively. According to overall survival, patients were separated into two groups: long (upper 24 months) and short (24 months or less) survivors. Long survivors (LS) represent 37.7% in the CIMAvax-EGF® vaccine, 49.3% in the Nimotuzumab, and 43.5% in the combination group. Adenocarcinomas (ADCs) tumors benefited from vaccine therapy, and squamous cell carcinomas with a nimotuzumab also benefited. A combination of both does not improve survival more than monotherapy. Nimotuzumab and CIMAvax-EGF® become an opportunity to treat refractory advanced cervical cancer.