Astellas : Phase 3 Study Of Xtandi In Metastatic Hormone-sensitive Prostate Cancer Meets Main Goal

(RTTNews) - Astellas Pharma Inc. (ALPMY) announced positive results from the Phase 3 China ARCHES study of Xtandi (enzalutamide) plus androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer or mHSPC versus placebo plus androgen deprivation therapy.

The study met its primary endpoint, demonstrating a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP).

At the topline analysis, the safety of Xtandi plus androgen deprivation therapy or ADT was broadly consistent with the known safety profile for the medication.

The study also met key secondary endpoints, demonstrating that treatment with XTANDI plus ADT notably reduced the risk of radiographic progression-free survival (rPFS) and increased the rate of patients with undetectable PSA versus placebo plus ADT.

The Study enrolled 180 men with metastatic hormone-sensitive prostate cancer in mainland China.

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