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:
- The survival benefit associated with PROVENGE was observed consistently across multiple patient subgroups, including those with prognostic factors known to be adversely correlated with overall survival, such as PSA, LDH, alkaline phosphatase, number of bone metastasis, Gleason score, performance status, and presence of pain;
- Of patients that received PROVENGE, 97.1% received at least one infusion and 92.2% received all three infusions. In addition, the median time from the first to the third infusion was 28 days;
- Sensitivity analyses provided no evidence that the use of docetaxel could account for the observed treatment difference with respect to overall survival;
- Results were consistent with and confirmed the findings of D9901, a Phase 3, randomized trial, in which the PROVENGE group had a median increase in survival of 4.5 months, a median survival of 25.9 months, and a 3-year survival rate of 34.1%;
- The time to objective disease progression was similar in the two study groups and consistent with results from other trials in this patient population; and
- Overall, 0.9% of patients in the PROVENGE group were unable to receive all three infusions because of infusion-related adverse events.
"PROVENGE has opened a new door in the treatment of advanced prostate cancer, providing patients with a clear and meaningful survival benefit, as well as a minimal and readily manageable side effect profile, with a short duration of therapy," said Paul Schellhammer, M.D., professor of urology at the Eastern Virginia Medical School and co-principal investigator of the IMPACT study.
SOURCE Dendreon Corporation