What is MDV3100

  MDV3100: MDV3100 is a new androgen receptor blocker that blocks the androgen receptor signaling pathway by blocking androgen-receptor binding, inhibiting androgen receptor nuclear translocation, and inhibiting the recruitment of costimulatory factors. The AFFIRM study is a multinational, multicenter, randomized, placebo-controlled phase III clinical study in which 1,199 patients with progressive mCRPC previously treated with docetaxel were randomized 2:1 to MDV3100 (160 mg/d, 800 patients) or placebo. The results of an interim analysis of the AFFIRM study, reported at the 2012 EAU Annual Meeting, showed that MDV3100 improved median OS by nearly 5 months (18.4 months vs. 13.6 months, p < 0.001) after a median follow-up of 14.4 months, with all secondary endpoints such as soft tissue metastases effectiveness (28.9% vs. 3.8%, p < 0.001) were also consistent with the primary endpoint, which was superior in the MDV3100 group. Of particular note, the incidence of adverse events in the treatment group was similar to that in the placebo group. Based on these results, the IndependentData Monitoring Committee (IDMC) recommended that the study be terminated, unblinded, and that patients in the placebo group receive MDV3100.