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Prostate cancer immunotherapy trial terminated

Independent data monitoring committee found an imbalance in deaths between the two treatment groups.

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Cell Genesys Inc. recently announced the termination of VITAL-2, its phase-3 trial comparing GVAX immunotherapy plus docetaxel (Taxotere, Sanofi-aventis) with docetaxel plus prednisone in patients with advanced-stage prostate cancer.

The decision to halt the trial is a result of the company’s independent data monitoring committee’s safety review which revealed an imbalance in deaths between the two treatment arms, according to a press release.

The trial, which was the second of two phase-3 studies of GVAX immunotherapy in prostate cancer, began in June 2005 and enrolled 408 patients. All patients had hormone-refractory, metastatic prostate cancer and were symptomatic with cancer-related pain. The study included 115 trial sites across North America and the European Union.

The researchers reported 114 deaths, 67 of which occurred in the combination GVAX/docetaxel group and 47 in the docetaxel plus prednisone group. Though there is no evidence to support a specific cause of the disparity in the number of deaths, the company will assess the data to determine a potential cause.

By the request of the company, the independent data monitoring committee will conduct a futility analysis of VITAL-1, the other phase-3 trial of GVAX for prostate cancer.