PROVENGE/AVASTIN IMPACT PSA DOUBLING TIME IN PROSTATE CANCER.
The data were presented today by Brian Rini, M.D., assistant professor of medicine, University of California, San Francisco, at the 2005 Multidisciplinary Prostate Cancer Symposium.
Study Details & Results
Twenty-two patients with androgen-dependent prostate cancer who had undergone prior definitive surgical or radiation therapy were enrolled and treated in this Phase 2 trial, known as the P-16 study.
Provenge was given intravenously (IV) on weeks one, two and four. Patients were given 10 mg/kg of IV Avastin immediately following Provenge and continued every two weeks thereafter until disease progression or toxicity was observed. Disease progression was defined as a doubling of the baseline or nadir PSA value or the development of metastases. PSA measurements were recorded and PSADT was calculated.
The median pre-treatment PSADT for the 21 evaluable patients was 6.7 months and the median on-treatment PSADT was 12.7 months, an approximate 90 percent increase in PSADT (p = 0.004). Eight patients displayed at least a 200 percent increase (range, 212 percent - 758 percent) in PSADT while on study compared with their pretreatment rate of change. In addition, 41 percent of patients exhibited a decrease in their absolute PSA value from baseline (range, 6 to 72 percent). No patient on study had objective disease progression (defined as the onset of measurable bone or soft tissue metastatic disease). Four patients were removed from study due to toxicity (congestive heart failure, hypertension, cerebrovascular ischemia and proteinuria).
"These results provide encouraging proof-of-concept that Provenge can be safely combined and work synergistically with other immune-modulating therapies such as Avastin for the treatment of men with prostate cancer," said Dr. Rini. "PSA doubling time has become increasingly used as a measure of prostate cancer disease biology. The alteration in PSADT seen in this trial may reflect the biologic effect of this combination therapy. If proven effective, the combination of Provenge with Avastin, or other immune modulating therapies, could prove to be an appealing treatment alternative for prostate cancer patients."
Provenge is an active immunotherapy designed to stimulate the immune system to attack cells that express prostatic acid phosphatase (PAP), a protein expressed on approximately 95 percent of prostate cancer cells. Avastin is a VEGF inhibitor. VEGF is a pro-angiogenic protein with inhibitory effects on dendritic (DC) cells. VEGF inhibition with Avastin has been shown to result in enhanced tumor rejection after DC-based vaccination in pre-clinical models.
About Prostate Cancer
Prostate cancer is the number one 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 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.
Provenge is designed to stimulate a patient's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) 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 the 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. To learn more about the trial, go to http://www.dendreon.com.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp.
For more information, visit http://www.dendreon.com or call 206/829-1500.
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|Date:||Apr 1, 2004|
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