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news.US-based biotechnology company Cell Genesys has terminated Vital-2, the second of two Phase III clinical trials of Gvax immunotherapy for prostate cancer, which compares Gvax immunotherapy in combination with Taxotere to Taxotere plus prednisone in patients with advanced-stage prostate cancer.
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The company ended the trial as recommended by its independent data monitoring committee (IDMC) which observed an imbalance in deaths between the two treatment arms of the study. The IDMC based its recommendation on 114 deaths of which 67 occurred in the Gvax plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm.
The company plans to fully analyze the clinical data from these patients to attempt to understand the potential cause for the higher rate of deaths observed in the Gvax immunotherapy plus Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as other treatment variables.
In light of the IDMC’s observation with respect to Vital-2, the company has requested that the IDMC perform a previously unspecified futility analysis of Vital-1, the other Phase III clinical trial of Gvax immunotherapy for prostate cancer. The company expects the results of the Vital-1 futility analysis in approximately one month.