Astellas Pharma Inc. and Pfizer Inc.'s (PFE) Xtandi or enzalutamide improved overall survival in men with metastatic hormone-sensitive prostate cancer, as per a phase 3 ARCHES Study.
RTTNews | Sep 17, 2021 11:59PM EDT
23:59 Friday, September 17, 2021 (RTTNews.com) - Astellas Pharma Inc. and Pfizer Inc.'s (PFE) Xtandi or enzalutamide improved overall survival in men with metastatic hormone-sensitive prostate cancer, as per a phase 3 ARCHES Study.
The Phase 3, randomized, double-blind, placebo-controlled trial compared Xtandi plus androgen deprivation therapy versus placebo plus androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer and overall survival was a key secondary endpoint.
In the study, Xtandi plus ADT reduced the risk of death by 34% compared to placebo plus androgen deprivation therapy. Median overall survival, which represents the time from randomization to death due to any cause, was not reached in either treatment group. The safety profile in both study arms was consistent with findings from the primary analysis.
The companies jointly commercialize Xtandi in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.
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