Astellas Pharma, Pfizer announce Phase 3 ARCHES trial meets primary endpoint

Astellas Pharma (ALPMY) and Pfizer (PFE) announced that the Phase 3 ARCHES trial evaluating XTANDI plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer met its primary endpoint, significantly improving radiographic progression-free survival versus ADT alone. The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer. Detailed results will be submitted for presentation at an upcoming medical congress. XTANDI is currently approved in the U.S. and Japan for the treatment of CRPC and in the EU for the treatment of metastatic and high-risk non-metastatic CRPC. Since its initial approval in 2012, XTANDI has been prescribed to more than 330,000 men worldwide.
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