Dendreon up on Provenge Phase III data

On Thursday, DNDN was up $0.82 (13%) to $7.02 on 9.3 million shares after reporting three-year survival data from the Phase III D9902A trial of Provenge to treat asymptomatic, metastatic, androgen-independent prostate cancer. In the double-blind, U.S. trial, Provenge improved median survival by 20% over placebo. The results were not significant based on a log rank test but were significant based on a secondary analysis.

Also, a pooled analysis of D9902A and an earlier Phase III trial, D9901, showed a statistically significant 23% increase in median survival in the intent-to-treat population of 225 patients. DNDN has previously reported that neither trial met primary endpoint of time to disease progression in the overall population. D9901 showed a benefit in patients with Gleason scores of seven or less, but D9902A did not. D9902A was stopped early in 2002 after 98 patients were enrolled (see BioCentury Extra, Tuesday April 30, 2002). ...