Dendreon Corporation (Nasdaq: DNDN) announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE® (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC). The manuscript is published in the July 29, 2010 issue of the journal.
PROVENGE is the first product in a new therapeutic class known as autologous cellular immunotherapies to be approved by the U.S. Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic mCRPC.
The 512-patient multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study demonstrated that PROVENGE extended median survival by 4.1 months compared to control (25.8 months vs. 21.7 months) and reduced the risk of death by 22.5% compared to control>
"These results represent the beginning of a new era in the treatment of cancer, one in which a patient's own immune system is harnessed to fight the disease," said Philip Kantoff, M.D., lead author of the publication, co-principal investigator of IMPACT and Chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place PROVENGE as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC."
Results of the published IMPACT study also showed that: