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.
This is a game-changing agent.
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
