Team of PCF-Funded Researchers Present MDV3100 Trial Results at ASCO
June 2, 2012 -- A team of cancer researchers, including PCF-supported investigators Johann Sebastian De Bono MD, PhD with The Institute for Cancer Research, Andrew J. Armstrong MD, MSc with Duke University and Howard Scher MD with Memorial Sloan-Kettering Cancer Center, presented data results from a MDV3100 Phase III AFFIRM trial at the annual American Society of Clinical Oncology (ASCO) meeting.
“The clinical advancement of MDV3100 is one of the most important events in the history of prostate cancer research and the Prostate Cancer Foundation,” said Howard Soule, PhD, chief science officer and executive vice president of PCF. “For men whose disease has progressed since receiving hormone therapy and docetaxel chemotherapy, MDV3100 should provide a new therapy to extend survival.”
MDV3100, manufactured by Medivation and Astellas, has a novel mechanism of action, inhibiting the androgen receptor (AR) at three distinct points in the signaling pathway: 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.
MDV3100 directly blocks the activity of the androgen receptor, the engine of prostate cancer progression. In its Phase III clinical study, MDV3100 increased median survival by 4.8 months, providing a 37 percent reduction in the risk of death compared to placebo. Some patients have very durable remissions well beyond the average while some do not respond. Thus, the median survival is a statistical description for the FDA and clinical researchers.
MDV3100 is currently awaiting approval by the Food and Drug Administration (FDA), but has been recently cleared to proceed with an Expanded Access Program (EAP) for treatment-resistant metastatic prostate cancer patients previously treated with docetaxel chemotherapy.
“There’s an urgent need for more patients to get an improved outcome. For 50 years we had very little progress, and in the last five years, we’ve had five new agents that improve survival,” says de Bono, lead investigator of the 1,200-patient study, which Medivation called Affirm. The Medivation drug is a particular standout, he says, because at least in the Affirm study, “these patients are dying but at least they are living longer, with better quality of life. These were patients with only months left to live. These results were particularly impressive because of that.”
The research and development period for MDV3100 has been a short nine years. PCF’s total investment of $14.75 million in MDV3100 has been supported by investments in the Prostate Cancer Clinical Trials Consortium.
Additional authors of the study include Karim Fizazi, Fred Saad, Cora N. Sternberg, Kurt Miller, Peter Mulders, Kim N. Chi, Mohammad Hirmand and Brian Selby.