Dendreon Corp. has completed enrollment of more than 500 U.S. and Canadian patients in the phase III IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) clinical trial of sipuleucel-T (Provenge) for the treatment of advanced prostate cancer. The IMPACT study is a double-blind, randomized, placebo-controlled trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving sipuleucel-T versus placebo.
Dendreon Corp. has completed enrollment of more than 500 U.S. and Canadian patients in the phase III IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) clinical trial of sipuleucel-T (Provenge) for the treatment of advanced prostate cancer. The IMPACT study is a double-blind, randomized, placebo-controlled trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving sipuleucel-T versus placebo.
Earlier this year, Dendreon received a complete response letter from the FDA that asked for additional evidence that would support the efficacy of sipuleucel-T. Subsequently, Dendreon received confirmation that the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the biologics license application and support the efficacy claim for sipuleucel-T.
The primary endpoint of the study is overall survival, and the secondary endpoint is time to objective disease progression. Patients with metastatic androgen-independent prostate cancer were eligible. The company currently expects an interim analysis for overall survival to be performed in the second half of 2008.
Enrolling 500-plus patients into the study is a “major achievement,” as the data from this trial may provide the FDA with the additional clinical data needed for the approval of sipuleucel-T, according to a Dendreon statement.