We are about to finally get a more formal presentation of the great news we have all been waiting to hear. Medivation Inc. and Astellas Pharma Inc. announced that data from their Phase 3 AFFIRM trial, evaluating MDV3100 in men with advanced prostate cancer, will be highlighted in a late-breaking oral presentation at the upcoming American Society of Clinical Oncology 2012 Genitourinary Cancers Symposium in San Francisco, CA.
Howard I. Scher, M.D., chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center, and the co-principal investigator of the AFFIRM study will give the hour and a half presentation on Thursday, February 2.
The title of his presentation is: Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer postdocetaxel: Results from the phase III AFFIRM study
The Phase 3 AFFIRM trial is a randomized, double-blind, placebo-controlled, multinational trial evaluating MDV3100 (160 mg/day) versus placebo in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy.
In November 2011, the Independent Data Monitoring Committee overseeing the AFFIRM trial informed the companies of positive overall survival results from the planned interim analysis and recommended that the study be stopped early and that all patients who received placebo be offered MDV3100. As a result the FDA has granted MDV3100 Fast Track designation for the prostate cancer post-chemotherapy indication.
We all wait on the edge of our seats to have the FDA approve this much needed drug.
Joel T Nowak, M.A., M.S.W.