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Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
Date:4/28/2009

- Extended Median Survival by 4.1 Months and Increased 3-Year Survival by 38 Percent Compared to Placebo -

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CHICAGO and SEATTLE, April 28 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that its pivotal Phase 3 IMPACT study of PROVENGE(R) (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of significantly improving overall survival compared to placebo. The data were presented at the American Urological Association (AUA) Annual Meeting.

The intent-to-treat analysis demonstrated that:

  • PROVENGE extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months);
  • PROVENGE improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%);
  • The IMPACT study achieved a p-value of 0.032, successfully exceeding the pre-specified level of statistical significance defined by the study's design (p-value less than 0.043), and PROVENGE reduced the risk of death by 22.5% compared to placebo (HR=0.775); and
  • PROVENGE exhibited a favorable safety profile consistent with prior trials.

"These results confirm the clinical value of PROVENGE to prolong survival in patients with advanced prostate cancer. Moreover, it validates the longstanding but elusive aspiration to harness a patient's own immune system to fight cancer," said Philip Kantoff, MD, head of the prostate cancer program and chief of the division of solid tumor oncology at the Dana-Farber Cancer Institute and Harvard Medical School and a principal investigator of the IMPACT study.

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SOURCE Dendreon Corporation
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