Survival Benefit Propels Prostate Cancer Vaccine to Phase III Trial

Published: Wednesday, Jul 03, 2013
James L. Gulley, MD, PhD

James L. Gulley, MD, PhD

An investigational prostate cancer vaccine has shown potential to improve survival in patients with metastatic castration-resistant prostate cancer (CRPC), according to the results of early clinical evaluations.

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Dr. Gulley on the Adverse Event Profile for PROSTVAC
In a phase II, randomized, double-blind, placebo-controlled trial, 125 patients with minimally symptomatic metastatic CRPC were randomized 2:1 to PROSTVAC-VF or to control empty vectors (J Clin Oncol. 2010;28:1099-1105). Patients randomized to the immunotherapy received a priming dose of PROSTVAC-V, followed by six booster doses of PROSTVAC-F given with low-dose granulocyte- macrophage colony-stimulating factor (GM-CSF).

pox viral vaccines

How pox viral vaccines activate tumor-associated antigen specific T- cells.

Laboratory and pathology results showed that 12 of 32 patients had decreases in PSA levels, accompanied by modest tumor regression in two of the 12 cases. Median overall survival was 26.6 months, as compared with a survival predicted at 17.4 months by the Halabi nomogram.

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