Dendreon Provenge misses endpoint
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Dendreon's therapeutic prostate cancer vaccine Provenge did not reach statistical significance for the primary endpoint of a Phase III trial, the firm announces Jan. 11. "Final analysis of the primary endpoint, time to disease progression, in [study] D9902A did not show a statistically significant delay…in the overall group or in the Gleason score subgroups," the firm reports. An interim analysis of the secondary measure of overall survival showed similar results to an earlier study, D9901, which demonstrated a survival benefit at three years. Dendreon plans to complete analysis of 9902A in the second half of 2005. The study was halted in 2002 after 98 patients were enrolled and D9901 showed no significant benefit in TTP. Another Phase III study, D9902B, is ongoing...