Data from a pivotal Phase III study of Dendreon's prostate cancer vaccine Provenge (sipuleucel-T) met its primary endpoint of improving overall survival. On the day of the news, April 14, shares in the US biotechnology firm soared 132.7% to $16.99.
In the trial, which involved 512 men with metastatic androgen-independent prostate cancer, the magnitude of the survival difference observed in the intent-to-treat population achieved the pre-specified level of statistical significance.
The agent could become the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer. Detailed results from the trial will be presented at the American Urological Association's annual meeting on April 28.
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