BVAC-C is a B cell- and monocyte-based immunotherapeutic vaccine transfected with recombinant HPV E6/E7 gene and loaded with alpha-galactosyl ceramide, a natural killer T cell ligand. It may have activity against HPV positive cancer. This phase I study was performed to determine the safety and tolerability of BVAC-C in patients with HPV type 16 or 18 positive recurrent cervical carcinoma and to preliminarily assess antitumor activity and immunologic correlates.
Ten patients who had experienced recurrence after at least one prior platinum-based combination chemotherapy, received three intravenous infusion of BVAC-C every 4 weeks in dose-escalating three-patient cohorts at 1x107, 4x107, or 1x108 cells/dose.
BVAC-C was well tolerated: grade 1 fever or myalgia were the most frequently observed without any grade 3 or 4 toxicity. One patient expired 3 weeks following 3rd dose for clinical disease progression. Of the 8 evaluable cases, one partial responses (12.5 %), and four stable diseases (50%) were seen. Three patients are surviving more than a year. Adenocarcinoma and bulky tumor burden were associated with poor response to the therapy. Immunologic response analysis showed that BVAC-C induced activation of natural killer T cells, natural killer cells, and HPV E6/E7 specific CD4 and CD8 T cells upon vaccinations in all patients evaluated. More follow-up results will be presented.
BVAC-C is well tolerated and associated with evidence of antitumor activity in HPV 16 or 18 positive cervical carcinoma. We are now planning further phase 2 efficacy trial.
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All authors have declared no conflicts of interest.