SAN FRANCISCO, CA and TOKYO -- (Marketwire) -- 01/30/13 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that six abstracts related to enzalutamide research will be presented on Thursday, February 14 at the American Society of Clinical Oncology (ASCO) 2013 Genitourinary (GU) Cancers Symposium in Orlando, Florida.

Oral Abstract Session A from 2:03-2:15pm ET:

  • (Abstract #6) Impact of on-study corticosteroid use on efficacy and safety in the Phase 3 AFFIRM study of enzalutamide, an androgen receptor inhibitor. Presenter: Howard I. Scher - Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center

General Poster Session A from 11:45am-1:15pm ET and again from 5:05-6:35pm ET:

  • (Abstract #18) Enzalutamide monotherapy: Phase 2 study results in hormone-naïve prostate cancer patients. Presenter: Bertrand Tombal - Université Catholique de Louvain, Cliniques Universitaires Saint-Luc
  • (Abstract #63): Enzalutamide in combination with docetaxel in men with prostate cancer (PC): Preliminary results from a phase 1 study. Presenter: Mark T. Fleming - Virginia Oncology Associates
  • (Abstract #16) Improved outcomes in elderly patients with metastatic castration-resistant prostate cancer (mCRPC) treated with the androgen receptor inhibitor enzalutamide: Results from the Phase 3 AFFIRM trial. Presenter: Cora N. Sternberg - San Camillo and Forlanini Hospital
  • (Abstract #17) Effect of enzalutamide on health-related quality of life (HRQoL) in men with metastatic castration-resistant prostate cancer (mCRPC) following docetaxel-based therapy: Results from the AFFIRM study. Presenter: Kurt Miller - Charité-Universitätsmedizin Berlin
  • (Abstract #20) Long-term responders to enzalutamide during the phase 3 AFFIRM trial: Baseline characteristics and efficacy outcomes. Presenter: Mark T. Fleming - Virginia Oncology Associates

About XTANDI®

XTANDI® (enzalutamide) capsules is an oral, once-daily androgen receptor inhibitor. XTANDI was approved by the FDA on August 31, 2012 for the treatment of metastatic castration-resistant prostate cancer for patients who have previously received docetaxel (chemotherapy). A Marketing Authorization Application for XTANDI is currently under review by the European Medicines Agency (EMA).

The efficacy and safety of XTANDI were assessed in the randomized, placebo-controlled, global phase 3 AFFIRM clinical trial. A total of 1,199 patients with mCRPC who had previously received docetaxel were randomized 2:1 to receive either XTANDI orally at a dose of 160 mg once daily (N = 800) or placebo (N = 399). Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. The primary endpoint of the trial was OS.

XTANDI-treated patients had a statistically-significant improvement in median OS compared to the placebo group: 18.4 months in the XTANDI group versus 13.6 months in the placebo group (P < 0.0001). XTANDI provided a 37% reduction in risk of death compared to placebo (hazard ratio = 0.631). Seizure occurred in 0.9% of patients on XTANDI and 0% of the placebo-treated patients. The most common adverse reactions (