Dendreon Announces Interim Data from Phase 3 PROVENGE IMPACT Trial
[The 95% confidence interval for the HR is quite wide.
Trading is halted until 9:50 AM.]
SEATTLE, October 6, 2008 - Dendreon Corporation (Nasdaq: DNDN) announced today that it has completed the planned interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial designed to assess the safety and efficacy of the investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with metastatic androgen-independent prostate cancer. While Dendreon remains blinded to the data, the independent data monitoring committee (IDMC) reported to Dendreon a 20 percent reduction in the risk of death in the PROVENGE arm relative to placebo (Hazard Ratio= 0.80; 95% Confidence Interval [0.610-1.051]) . The IDMC observed no safety concerns and recommended that the study continue to its final analysis.
"The treatment effect we have observed in this interim analysis is consistent with that observed in the integrated analysis of our previous Phase 3 trials in this patient population when analyzed at a similar 24-month follow-up time," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Given the delayed treatment effect we have seen in previous studies, we are pleased to see evidence suggesting a prolongation of survival in the PROVENGE arm at the time of the interim analysis, as well as a favorable safety profile."
At the final analysis, which is anticipated in the middle of 2009, if the study demonstrates approximately a 22 percent reduction in the risk of death, based on 304 events, the company would expect the study to meet its primary endpoint of overall survival.
"We look forward to the final results next year and the opportunity to make PROVENGE available to the many men with advanced prostate cancer who currently have few appealing treatment options," said Dr. Gold.
The IMPACT trial is a randomized, double-blind, placebo-controlled Phase 3 study which enrolled 512 men with metastatic, androgen-independent prostate cancer with a primary endpoint of overall survival. Following the U.S. Food and Drug Administration (FDA) Advisory Committee vote that there was substantial evidence of efficacy of PROVENGE and that PROVENGE was reasonably safe, the FDA requested additional clinical data to support the proposed efficacy claim. The FDA previously agreed that a positive final analysis for overall survival from the IMPACT trial would be sufficient to meet its request for additional clinical information to support the proposed efficacy claim for PROVENGE.
About Hazard Ratios
The hazard ratio is an estimate of the treatment effect in the treated versus the control group in a trial. The hazard ratio reported means that a PROVENGE patient who at the time of the interim analysis has 0.80 times the chance of dying compared to someone in the placebo group. Its reciprocal, 1.25, means a placebo patient has 1.25 times the chance of dying compared to someone in the PROVENGE group (this is the method that hazard ratios were reported in our previous trials).
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