Dendreon Corporation announced Tuesday that it has met its primary endpoint of improving overall survival compared to a placebo control in its pivotal Phase III IMPACT study of provenge (sipuleucel-T) in men with advanced prostate cancer.
The open discussion from the International Society for Biological Therapy of Cancer’s (iSBTc) November 2007 educational forum entitled the 'The Dendreon Debate', held during the 22nd Annual Meeting in Boston, resulted in general agreement of the FDA's decision to await the results of Phase III studies. Those results were announced Tuesday, April 14, 2009 and opened a new door for cancer immunotherapies.
“Today is a historic day for patients, our industry, the scientific community, and certainly for Dendreon,” said Dr. Mitchell Gold, president and CEO. In a statement, he noted that the studies “have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies."
Although many of iSBTc’s members have been investigating cancer immunotherapies and achieving successes for decades, none have yet been approved by the FDA. These positive results provide a pivotal success for those dedicated to cancer immunotherapies. “The successful outcome from the Phase III IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer” noted Gold.
It is hoped that this breakthrough will be the first of many in using the body’s own immune system to fight cancer. With the success of provenge, iSBTc will continue to focus educational programming on immunotherapy’s potential in a variety of cancers including breast, kidney, melanoma and lung.
Dr. Bernard Fox, iSBTc President shared his enthusiasm. “Today's announcement brings genuine hope to thousands of prostate cancer patients and provides researchers the world over with reason to redouble their efforts employing innovative biological treatments to improve the lives of cancer victims.”
Founded in 1984, the International Society for Biological Therapy of Cancer (iSBTc) is a non-profit organisation of clinicians, researchers, students, post-doctoral fellows, and allied health professionals dedicated to improving cancer patient outcomes by advancing the development and application of biological therapy/immunotherapy through interaction, innovation and leadership.