Dendreon down on prostate cancer trial failure

The final analysis of the primary endpoint, time to disease progression, in the D9902A study, did not show a statistically significant delay in time to disease progression in the overall group or in the Gleason score subgroups.

However, the trial data did indicate encouraging secondary endpoint results. An interim analysis of overall survival in the intent-to-treat patient population indicated that both the survival rates and the median survival benefit compared to placebo are similar to the results observed in the final three-year survival analysis of the D9901 study, which demonstrated a survival benefit.

Despite investor fears, Dendreon remains positive about the future of Provenge at this stage and remains set on approval goals. “While D9902A is a relatively small study, we believe the data will contribute to the large body of information we have from the multiple clinical trials of Provenge,” said Dr Robert Hershberg, senior vice president and chief medical officer at Dendreon Corporation.

“We intend to utilize these data in our ongoing discussions with the FDA to determine the most expeditious route to obtain potential regulatory approval of Provenge.”

The D9902A study was originally designed to be the companion study to Dendreon’s completed first phase III study, D9901. The D9902A study was stopped in 2002 after 98 patients were enrolled when the analysis of D9901 showed that no significant benefit in time to disease progression had been observed in the overall group, but that a benefit was seen in the subgroup of patients with Gleason scores of seven and less. The company amended the D9902A protocol to become what is the ongoing D9902B pivotal phase III study.