Phase III ARCHES trial of Xtandi meets primary endpoint in prostate cancer.- Astellas Pharma + Pfizer.

Astellas Pharma and Pfizer announced that the Phase III ARCHES trial evaluating Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, significantly improving radiographic progression-free survival (rPFS) 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 (CRPC). The trial also included some patients who had received recent treatment with docetaxel for mHSPC, but whose disease had not progressed.

The primary endpoint of the trial was 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.Detailed results will be submitted for presentation at an upcoming medical congress.