MDV3100 in Clinical Development for Advanced PCa

MDV3100 is an investigational therapy in clinical development for the treatment of advanced prostate cancer.
Overview
MDV3100 is the first triple-acting, oral anti-androgen in development for the treatment of advanced prostate cancer. The treatment of advanced prostate cancer represents a critical unmet medical need, as patients with this stage of the disease have few treatment options and a poor prognosis.

MDV3100 has a novel mechanism of action that is unlike that of the leading anti-androgen (hormonal) therapy bicalutamide. The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide a more complete suppression of the androgen receptor pathway than bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science in April 2009 demonstrated that MDV3100 is superior to bicalutamide in each of these three actions. Click here for Science article.

Medivation is evaluating MDV3100 in collaboration with Astellas, in an ongoing, open-label, U.S., Phase 1-2 study. The interim results showed that MDV3100 was associated with anti-tumor activity in patients who had become resistant to bicalutamide or other standard anti-androgen treatments, including both patients who had failed prior chemotherapy and patients who were chemotherapy naïve. Anti-tumor activity was demonstrated by reductions in prostate-specific antigen levels, improvement or stabilization in tumors that had spread to soft tissue or bone, and a decrease in circulating tumor cells, which has been associated in published literature with improved survival in patients with castration-resistant prostate cancer.

The Phase 3 AFFIRM trial is currently enrolling men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. Click here for clinical trial information.