On January 30, 2020 Bayer reported results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a statistically significant improvement in overall survival (OS) in patients receiving darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT (Press release, Bayer, JAN 30, 2020, View Source [SID1234553678]).

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Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT. Detailed data on the updated OS and other additional endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.

Darolutamide, an oral androgen receptor inhibitor (ARi), has been approved in the U.S., Brazil and Japan, and filings in the European Union and other regions are underway or planned by Bayer. The compound is developed jointly by Orion Corporation and Bayer.