"Median survival benefit of 4.5 months is longest ever reported from a Phase 3 study in advanced prostate cancer."
ORLANDO, FLA., February 17, 2005 - Dendreon Corporation announced today that Provenge®, the Company's investigational vaccine for the treatment of prostate cancer, "significantly improved survival" in men with asymptomatic, metastatic androgen-independent (hormone-refractory) prostate cancer when compared to patients receiving placebo.
Patients receiving Provenge had a 4.5 month improvement in their median survival and a greater than 3-fold increase in survival at 36 months when compared to patients receiving placebo.
"The survival benefit seen with Provenge is the largest ever reported in this patient population with any therapy," said Dr. Small. "This survival benefit, combined with a favorable safety profile, has the potential to provide an important new treatment option for prostate cancer patients."
In Study D9901, patients receiving Provenge had a median survival of 25.9 months compared to 21.4 months for patients in the placebo arm, a 4.5 month improvement.
Patients receiving placebo had a relative risk of dying that is 70 percent higher than those patients receiving Provenge.
In addition, 34 percent of patients receiving Provenge were alive at 36 months compared to 11 percent of patients receiving placebo.
The survival benefit seen with Provenge was independent of a patient's Gleason Score, a common measure of disease severity. Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.
The study was a double-blind, placebo-controlled Phase 3 trial evaluating Provenge in men with asymptomatic, metastatic androgen independent prostate cancer.
The study was designed to measure time to disease progression and time to development of disease-related pain in men with androgen independent prostate cancer.
A 36 month final survival analysis was required per the study design. The study randomized 127 men to receive three infusions of Provenge or placebo over a four-week period.
Provenge is designed to stimulate a patient's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette™ technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).
Provenge is being further evaluated in an ongoing, pivotal Phase 3 trial (D9902B) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
Provenge also has Fast Track designation. The double-blind, placebo-controlled trial is enrolling patients at leading cancer centers around the country.
A pivotal Phase 3 trial of Provenge (Trial D9902B) is currently underway in men who have asymptomatic, metastatic, androgen independent prostate cancer (AIPC) with a Gleason score of 7 and less. The trial compares Provenge to an inactive product (placebo) to determine if Provenge significantly delays time to disease progression and time to onset of disease-related pain. This pivotal trial is enrolling patients at medical centers throughout the country and results of the trial, if successful, will serve as the basis for a marketing application.
A Phase 3 clinical trial of Provenge (Trial P-11), is also underway to evaluate the safety and potential effectiveness of Provenge in treating men with early stage, androgen dependent prostate cancer. Men whose prostate cancer is responsive to hormone treatment are considered androgen dependent. In addition, Dendreon supplies the National Cancer Institute with Provenge for use in a Phase 2 clinical trial (Trial P-16), testing Provenge together with Genentech, Inc.'s Bevacizumab (Avastin) to treat patients with androgen dependent prostate cancer.
"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" --Dendreon Chief Executive Mitchell Gold, April 14, 2009. Read more.
Information on this website is not intended as medical advice nor to be taken as such. Consult qualified physicians specializing in the treatment of prostate cancer. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained on this website.
Mitchell Gold, CEO of Dendreon Inc., Discusses Provenge (sipuleucal-T) immunology
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