May 25, 2012 (Atlanta) — A first-in-class drug, the androgen-receptor signaling inhibitor enzalutamide (MDV3100), has shown a survival benefit in men with post docetaxel prostate cancer. The risk for death decreased by 37% relative to placebo, extending survival by more than 4 months, according to findings from the phase 3 AFFIRM study.
According to the researchers, enzalutamide, an oral hormonal agent, competitively inhibits the binding of androgens to the androgen receptor. It also inhibits androgen receptor nuclear translocation and the association of the receptor with DNA. Enzalutamide displayed activity during phase 1 and 2 trials in pre- and post-chemotherapy patients with progressive castration-resistant prostate cancer.
Trials in earlier-stage disease with this agent are ongoing. One large multicenter trial will evaluate this agent in patients who have not received docetaxel. There are also plans to evaluate it in M0 castrate-resistant prostate cancer and in the androgen-sensitive disease state, Dr. Shore said.
"This is a game-changing agent because of its tolerability and, more important, its efficacy and ease of administration," he said. "I think this is an exceptionally optimistic and exciting time for both clinicians and patients."
American Urological Association (AUA) 2012 Annual Scientific Meeting