At 9 am this morning, Dendreon Corporation (Nasdaq: DNDN) announced the long awaited interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT (Immunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B). The clinical trial is designed to assess the safety and efficacy of the investigational active cellular immunotherapy Provenge® (sipuleucel-T) in men with metastatic androgen-independent prostate cancer. 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.
Mitchell H. Gold, M.D., president and chief executive officer of Dendreon said, “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. 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.”
The final analysis of the trial will not be made until the middle of 2009. Dendreon is hoping to