NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and Astellas Pharma Inc. (ALPMY) announced the results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer, or mHSPC. The companies said the results showed that XTANDI (enzalutamide) plus androgen deprivation therapy met the primary endpoint by significantly reducing the risk of radiographic progression or death by 61% versus androgen deprivation therapy alone. Adverse events in the ARCHES clinical trial were generally consistent with those reported in enzalutamide clinical trials in patients with castration-resistant prostate cancer, the companies noted.
Based on the ARCHES results, the companies intend to discuss these data with global health authorities to potentially support a new indication for XTANDI in men with metastatic hormone-sensitive prostate cancer.
XTANDI is currently approved in the U.S. and Japan for the treatment of castration-resistant prostate cancer and in the EU for the treatment of metastatic and high-risk non-metastatic castration-resistant prostate cancer.
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