It was announced today that the Phase 3 ARCHES trial which evaluated XTANDI (enzalutamide) along with 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.
Also, preliminary safety analysis of the trial is consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer (CRPC).
Currently, Xtandi is approved in the castrate resistant stage of advanced prostate cancer, the results of this trial should be adequate to have the FDA expand the drug’s label to include men who are still hormone sensitive, but have metastatic disease.
If it is approved, Xtandi will join Zytiga plus prednisone in this disease stage.
For more information about the ARCHES (NCT02677896) trial go to www.clinicaltrials.gov.