Astellas Pharma and Pfizer announced new data from the Phase 3 ARCHES trial evaluating Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC).

ARCHES (NCT02677896) is a randomized, double-blind placebo-controlled, multinational trial which randomized 1150 patients with mHSPC to either Xtandi 160mg daily or placebo plus ADT (luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy). Radiographic progression-free survival (rPFS), the primary endpoint, was 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. 

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In the study, treatment with Xtandi plus ADT led to significant improvements in rPFS compared with ADT alone. Initial safety data from the trial appeared similar to the safety profile of Xtandi in previous clinical trials in castration-resistant prostate cancer (CRPC). Full details will be submitted for presentation at an upcoming medical conference. 

Xtandi, an androgen receptor inhibitor, is already approved to treat castration-resistant prostate cancer.  It is available as 40mg softgel capsules in 120-count bottles. 

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