It worked! Dendreon announced five minutes ago that the pivotal Phase 3 IMPACT study of PROVENGE (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control (i.e. equal to or greater than 22% difference). 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.

Here was CEO’s Mitchell Gold’s comments:

“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. We are immensely grateful to our clinical investigators and the more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies. The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer.”

Truly a new era for cancer. IguanaBio will be live Twittering the webcast. Follow us!

Image from cnbc

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