Bayer and Orions Nubeqa phase III ARASENS trial in metastatic hormone-sensitive prostate cancer meets primary endpoint

The phase III ARASENS trial investigating the use of the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary endpoint. In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT. The overall incidence of reported adverse events was similar between treatment arms. Detailed results of the study are planned to be presented at an upcoming scientific congress. The ARASENS trial is the only phase III randomized, multi-center, double-blind trial which was prospectively designed to evaluate the efficacy and safety of a combination of an ARi with docetaxel and ADT compared to docetaxel and ADT in patients with mHSPC. Darolutamide is approved in multiple markets around the world, including the US, the European Union, Japan and China, under the brand name Nubeqa, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Filings in other regions are underway or planned. The product is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

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