title: GM-CSF gene-modifed cancer cell immunotherapies: of mice and men.
abstract: GVAX cancer immunotherapies are composed of whole tumor cells genetically modified to secrete the immune stimulatory cytokine, granulocyte-macrophage colony-stimulating factor (GM-CSF), and then irradiated to prevent further cell division. Both autologous (patient specific) and allogeneic (non-patient specific) GVAX platforms have been evaluated either as single agents or in combination with other immunomodulatory strategies. Many early-phase clinical trials have now been completed. Results have consistently demonstrated a favorable safety profile manifested primarily by injection site reactions and flu-like symptoms. Consistent evidence of immune activation and clinical activity, including radiologic tumor regressions, has been seen across multiple cancer indications in both early- and late-stage disease. Phase 3 trials evaluating an allogeneic GVAX immunotherapy product in prostate cancer are under way.
authors.affiliation: Cell Genesys, Inc., San Francisco, California 94080, USA. kristen.hege@cellgenesys.com
authors.forename: Kristen M
authors.initials: KM
authors.lastname: Hege
authors.forename: Karin
authors.initials: K
authors.lastname: Jooss
authors.forename: Drew
authors.initials: D
authors.lastname: Pardoll
mesh_terms: D000818:Animals; D019496:Cancer Vaccines / Q000276:immunology*; D017326:Clinical Trials, Phase III as Topic; D004359:Drug Therapy, Combination; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000276:immunology*; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D051379:Mice; D009369:Neoplasms / Q000276:immunology / Q000628:therapy; D014161:Transduction, Genetic; D014407:Tumor Cells, Cultured / Q000276:immunology
chemical_list: D019496:Cancer Vaccines; D016178:Granulocyte-Macrophage Colony-Stimulating Factor