GVAX Prostate cancer vaccine: Phase I data

An open-label, Dutch Phase I trial in 28 patients with metastatic CRPC showed that 53% of patients receiving BioSante's GVAX Prostate cancer vaccine plus 0.3-5 mg/kg ipilimumab achieved at least stable disease, with 2 patients showing regression of metastases. Additionally, GVAX plus 3 or 5 mg/kg ipilimumab led to >50% reductions in PSA from baseline in 7 patients. Median duration of PSA response was 12 months. The dose-escalation portion of the trial enrolled 12 patients to receive intradermal GVAX Prostate every 2 weeks plus 0.3-5 mg/kg ipilimumab every 4 weeks for 24 weeks, while the expansion portion enrolled 16 patients to receive GVAX Prostate plus 3 mg/kg ipilimumab. Data were published in The Lancet Oncology. BioSante said the trial was conducted in cooperation with Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.), which markets ipilimumab as Yervoy to treat unresectable or metastatic melanoma. ...