Dendreon (DNDN) Said PROVENGE Significantly Prolongs Survival for Men With Prostate Cancer
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Dendreon Corporation (Nasdaq: DNDN) announced that its pivotal Phase 3 IMPACT study of PROVENGE in men with advanced prostate cancer met its primary endpoint of significantly improving overall survival compared to placebo.
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.
Shares of DNDN plunged 45% ahead of the data.
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