title: Racotumomab-alum vaccine for the treatment of non-small-cell lung cancer.
abstract: Racotumomab-alum vaccine is an anti-idiotypic vaccine able to mimic the tumor-associated antigen NeuGcGM3. Different Phase I clinical trials and compassionate use studies demonstrated its low toxicity and capacity to induce a strong anti-NeuGcGM3 response, able to bind and directly kill tumor cells expressing the antigen. A Phase II/III randomized double-blind clinical trial in advanced non-small cell lung cancer patients showed a significant improvement in overall survival and progression-free survival for racotumomab-alum versus placebo. Patients who developed anti-NeuGcGM3 antibodies capable of binding and killing NeuGcGM3 expressing tumor cells showed significantly longer median survival times. The impact of using racotumomab-alum as switch maintenance followed by second-line therapy is currently being explored in a new randomized, multinational Phase III study.
authors.affiliation: Center for Molecular Immunology - Tumor Biology, 15th Ave and 217 Street, Atabey, Playa, Habana, Cuba.
authors.forename: Ana María
authors.initials: AM
authors.lastname: Hernández
authors.forename: Ana María
authors.initials: AM
authors.lastname: Vázquez
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000534:Alum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D058846:Antibodies, Monoclonal, Murine-Derived; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D002289:Carcinoma, Non-Small-Cell Lung / Q000628:therapy*; D005679:G(M3) Ganglioside / Q000031:analogs & derivatives / Q000037:antagonists & inhibitors / Q000276:immunology; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000534:Alum Compounds; D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D019496:Cancer Vaccines; D005679:G(M3) Ganglioside; C041524:aluminum sulfate; C000590234:racotumomab; C044298:N-glycolylneuraminyllactosylceramide
keywords: NSCLC; NeuGcGM3; anti-idiotypic antibody; clinical trial; vaccine