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news.Dendreon, a biotechnology company, has reported that the pivotal Phase III Impact study of Provenge in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control.
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According to Dendreon, the magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study’s design. The safety profile of Provenge appeared to be consistent with prior trials.
The 512-patient, multi-center, randomized, double-blind, placebo-controlled Impact study which enrolled men with metastatic androgen-independent prostate cancer was conducted under a special protocol assessment (SPA) agreement with the FDA.
Because the data meet the criteria and specifications outlined in its SPA agreement with the FDA, Dendreon intends to file an amendment to its existing biologic license application in the fourth quarter of 2009 to gain licensure of Provenge.
Mitchell Gold, president and CEO of Dendreon, said: “Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the Impact trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with Provenge may prolong survival. The successful outcome from the Phase III Impact study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer.”