title: CIMAvax EGF (EGF-P64K) vaccine for the treatment of non-small-cell lung cancer.
abstract: Epidermal growth factor receptor (EGFR) is overexpressed in many epithelial tumors and its role in the development of non-small-cell lung cancer (NSCLC) is widely documented. CIMAvax-EGF is a therapeutic cancer vaccine composed by recombinant EGF conjugated to a carrier protein and emulsified in Montanide ISA51. Vaccination induces antibodies against self-EGF that block EGF-EGFR interaction and inhibit EGFR phosphorylation. Five clinical trials were conducted to optimize vaccine formulation and schedule. Then, two randomized studies were completed in advanced NSCLC, where CIMAvax-EGF was administered after chemotherapy, as 'switch maintenance'. The vaccine was very well tolerated and the most frequent adverse events consisted of grade 1/2 injection site reactions, fever, headache, vomiting and chills. CIMAvax was immunogenic and EGF concentration was reduced after vaccination. Subjects receiving a minimum of 4 vaccine doses had a significant survival advantage. NSCLC patients with high EGF concentration at baseline had the largest benefit, comparable with best maintenance therapies.
authors: a 1 Center of Molecular Immunology, Havana, Cuba.
authors: Tania
authors: T
authors: Crombet Ramos
authors: a 1 Center of Molecular Immunology, Havana, Cuba.
authors: Pedro Camilo
authors: PC
authors: Rodríguez
authors: b 2 Hermanos Ameijeiras Hospital, Havana, Cuba.
authors: Elia
authors: E
authors: Neninger Vinageras
authors: a 1 Center of Molecular Immunology, Havana, Cuba.
authors: Beatriz
authors: B
authors: Garcia Verdecia
authors: a 1 Center of Molecular Immunology, Havana, Cuba.
authors: Agustin
authors: A
authors: Lage Davila
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000276:immunology* / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000276:immunology* / Q000628:therapy; D000068818:Cetuximab / Q000627:therapeutic use; D004815:Epidermal Growth Factor / Q000235:genetics*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000276:immunology*; D006801:Humans; D016233:Immunotherapy, Active; D008175:Lung Neoplasms / Q000276:immunology* / Q000628:therapy; D010766:Phosphorylation; D014611:Vaccination
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C550107:CIMAvax EGF; D019496:Cancer Vaccines; C527969:necitumumab; D004815:Epidermal Growth Factor; C512478:EGFR protein, human; D066246:ErbB Receptors; D000068818:Cetuximab
keywords: cancer vaccine; clinical trials; epidermal growth factor; epidermal growth factor receptor; lung cancer; non-small-cell lung cancer