Dendreon Corporation (Nasdaq: DNDN) announced that the pivotal Phase 3 IMPACT study of PROVENGE (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control.
The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study’s design.
The safety profile of PROVENGE appeared to be consistent with prior trials.
The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
PROVENGE is Dendreon’s investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient’s own immune system against cancer.
Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association’s Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.
“Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE may prolong survival,” said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “We are immensely grateful to our clinical investigators and the more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies.”
“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer,” continued Dr. Gold.
Because the data meet the criteria and specifications outlined in its Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of this year to gain licensure of PROVENGE.
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
Source: Dendreon Corporation, USA