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Pfizer (PFE), Astellas Pharma Inc. Reports Amendments to Clinical Research Protocols for Two Phase 3 Trials of Enzalutamide

August 22, 2018 5:01 PM EDT

Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). These amendments accelerate timelines for the anticipated primary completion dates of both trials.

ARCHES is a randomized Phase 3 study evaluating the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in metastatic HSPC patients. The primary endpoint of the trial is radiographic progression-free survival (rPFS). Changes to the protocol... More