title: Technology evaluation: Allovectin-7, Vical.
abstract: Allovectin-7 is a gene transfer product consisting of the human leukocyte antigen HLA-B7 gene co-expressed with the beta2-microglobulin gene. Allovectin-7 is being developed as an immunotherapy approach for a variety of malignancies, with special focus on melanoma, and head and neck cancer. Efficacy results in the phase II setting appear to be promising; an 11% systemic response rate among the intent-to-treat population and 15% response rate in the evaluable population was observed in patients with refractory metastatic melanoma with disease limited to skin, lymph nodes and lung. Stable disease was seen in 19.2% of the intent-to-treat population and 25.9% of the evaluable population in the same group of patients. Treatment has been extremely well tolerated with the most common side effects including mild-to-moderate injection site reactions and flu-like symptoms, all of which resolved rapidly and decreased in incidence after the first injection. Current evaluation of the drug includes higher Allovectin-7 doses and injection of multiple tumors in metastatic melanoma patients. A phase III trial comparing Allovectin-7 plus dacarbazine versus dacarbazine in untreated patients with metastatic melanoma has been completed, and preliminary results are soon to be reported. Phase I/II data also indicate promising activity of Alovectin-7 in patients with advanced refractory head and neck squamous cell carcinoma, with 10% of 60 patients achieving partial response and 23% stable disease after one cycle of treatment. Trials of Allovectin-7 as an adjuvant treatment in earlier stages of disease evolution are planned.
authors.affiliation: Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, USA. galanis.evanthia@mayo.edu
authors.forename: Evanthia
authors.initials: E
authors.lastname: Galanis
mesh_terms: D000818:Animals; D019496:Cancer Vaccines / Q000009:adverse effects / Q000235:genetics / Q000378:metabolism / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004247:DNA; D004274:DNA, Recombinant; D015793:HLA-B7 Antigen / Q000235:genetics; D006258:Head and Neck Neoplasms / Q000276:immunology / Q000628:therapy; D006801:Humans; D050356:Lipid Metabolism; D008055:Lipids / Q000235:genetics / Q000627:therapeutic use* / Q000633:toxicity; D008545:Melanoma / Q000276:immunology / Q000628:therapy; D051379:Mice; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D010957:Plasmids / Q000235:genetics / Q000378:metabolism / Q000627:therapeutic use* / Q000633:toxicity
chemical_list: C096492:Allovectin-7; D019496:Cancer Vaccines; D004274:DNA, Recombinant; D015793:HLA-B7 Antigen; D008055:Lipids; D004247:DNA