Cell Genesys halts VITAL-2 GVAX trial

In another severe setback for the application of immunotherapy in the treatment of advanced prostate cancer, Cell Genesys has announced the early termination of the Phase III VITAL-2 clinical trial comparing GVAX + docetaxel to docetaxel + prednisone.

The VITAL-2 trial had enrolled over 400 men with advanced prostate cancer. At a routine safety review of the study data it was observed that 67 men in the GVAX + docetaxel arm of the trial had died compared to 47 men in the docetaxel + prednisone arm. This represents a 42 percent increase in the mortality rate for patients in the investigational arm of the trial.

Cell Genesys has stated that no specific explanation for the imbalance in deaths is available at this time, and that no new safety issues for GVAX when administered in combination with Taxotere have been identified. There is therefore no way at present to understand what could have led to such an unexpected outcome.

The Company intends to conduct an unplanned analysis of available data from the VITAL-1 trial in order to ensure that there is no evidence of similar clinical effects in this trial. The results of the analysis are projected for some time prior to the end of September.

2 Responses

  1. Are there any other companies performing trials with vaccines against prostate cancer?

  2. There are many organizations attempting to develop immunotherapeutic therapies for prostate cancer, in the US and elsewhere.

    The most advanced of these products is sipuleucel-T (Provenge), which could get regulatory approval as early as next year.

    ClinicalTrials.gov lists more than 65 trials of “vaccines” for treatment of prostate cancer, but the vast majority of these are early stage trials of products that are unlikely to make it to the market.

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