In a phase I trial, the ICT-107 vaccine (ImmunoCellular Therapeutics Ltd.), a dendritic cell vaccine prepared with six synthetic peptides from tumor-associated antigens, was administered to 16 newly diagnosed glioblastoma patients. Progression-free survival of these patients was an impressive 16.9 months, and median overall survival was 38.4 months (1), comparable to the survival results seen in the phase I DCVax trial. A recent update revealed that 5 year survival was 50% (in other words, half of the patients were still alive at 5 years).
A phase II trial of ICT-107 is underway for newly diagnosed glioblastoma, with estimated primary completion date of October 2014. A recent press release dated December 11, 2013 revealed preliminary survival results from this phase II trial. 124 patients were randomized to receive either the ICT-107 vaccine or a placebo vaccine with the patient’s own unprepared dendritic cells. 117 patients received at least 4 induction vaccinations with either ICT-107 or placebo. Among the per-protocol population (of 117 patients), patients who received the ICT-107 vaccine had a 3-month increase in progression-free survival, which was statistically significant. The ICT-107 group also had a 3-month increase in median overall survival which has not yet reached statistical significance. Although this is the first placebo-controlled immunotherapy trial to show a statistically significant progression-free survival advantage in glioblastoma, the 3-month increase in progression-free and overall survival does not meet expectations based on the outstanding results seen in the preliminary phase I trial. This is perhaps partially due to the fact that all patients in the phase I trial had surgery (none had biopsy only) and had no evidence of tumor progression following conventional radio- and temozolomide therapy, and were thus selected for improved survival outcomes.
Phase I trial of a multi-epitope-pulsed dendritic cell vaccine for patients with newly diagnosed glioblastoma. Phuphanich et al. 2013.
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Induction of CD8+ T-cell responses against novel glioma-associated peptides and clinical activity by vaccinations with alpha-type 1 polarized dendritic cells and polyinosinic-polycytidylic acid stabilized by lysine and carboxymethylcellulose in patients with recurrent malignant glioma. Okada et al. 2011.
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