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American Society Of Clinical Oncology Highlights

Executive Summary

Provenge cancer vaccine improves survival: Final three-year analysis of Dendreon's prostate cancer vaccine Provenge Phase III D9901 study shows a median survival of 25.9 months for Provenge compared to 21.4 months for placebo, a statistically significant 4.5 month improvement (p=0.01) that "was not due to any imbalances in the patient population," Dendreon reports May 14 at ASCO. An analysis of imbalances between immunotherapy and placebo populations showed no difference in subsequent use of chemotherapy after progression. "In addition, 34% of patients receiving Provenge were alive at 36 months compared to 11% of patients receiving placebo (p=0.0046)." The therapeutic vaccine was well-tolerated among the 127 men with hormone-refractory prostate cancer. An earlier interim analysis of the study did not show significance for time to progression. Provenge failed to meet the final endpoint of time to progression in a separate Phase III trial (D9902A). Dendreon has another pivotal Phase III trial (D9902B) underway, under a special protocol assessment with FDA...

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