Medivation Offers Pivotal Phase III Trial of Enzalutamide Initiated in Metastatic Hormone Sensitive Prostate Cancer

Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the ARCHES (AR Inhibition with ChemoHormonal Therapy in Men with MEtastatic Castrate Sensitive Prostate Cancer) Phase III registrational trial, which will evaluate the efficacy and safety of enzalutamide with androgen deprivation therapy (ADT) versus placebo with ADT in metastatic hormone sensitive prostate cancer (mHSPC) patients, has been initiated and the first patient has been randomized. Prostate cancer is the most commonly diagnosed cancer and the second-leading cause of cancer death in men in the United States. According to the American Cancer Society, approximately 181,000 new cases of prostate cancer will be diagnosed, and 26,000 men will die of prostate cancer in the United States in 2016.(i) Androgen deprivation therapy, which reduces the levels of androgens (male hormones), is the standard of care for patients with mHSPC. The ARCHES trial will investigate whether the addition of enzalutamide to ADT may benefit this patient population compared to ADT alone. "This trial targets an important patient population as we advance the development of enzalutamide," said Mohammad Hirmand, M.D., interim chief medical officer, Medivation. "The initiation of this trial demonstrates our ongoing commitment to fully develop enzalutamide in this serious disease." "Dosing of the first patient in this trial demonstrates our ongoing commitment to continuing to investigate enzalutamide," said Claire Thom, Pharm D., senior vice president and oncology therapeutic area head, Astellas. The global, Phase III, randomized, double-blind, placebo-controlled study, which is being led by Astellas, will evaluate the efficacy and safety of enzalutamide with ADT versus placebo with ADT in patients with mHSPC. ARCHES will enroll approximately 1,100 patients with mHSPC at approximately 250 centers globally. The primary endpoint of the trial is radiographic progression-free survival (rPFS), defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review or death, whichever occurs first. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily versus placebo, administered with ADT. For more information about this trial, visit www.clinicaltrials.gov, trial identifier NCT02677896.