Orion Corporation and Bayer are expanding the global clinical development program for the oral androgen receptor inhibitor (ARi) darolutamide in the area of prostate cancer.

A new Phase III study ARANOTE will evaluate the compound in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study adds to the robust development program for the compound, including the Phase III study ARASENS, which investigates darolutamide in a triple combination with ADT and docetaxel compared to doxetacel and ADT alone in men with mHSPC.

“Darolutamide is currently approved for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Now, it is naturally important that we also evaluate the potential of darolutamide in other stages of the disease to offer men with metastatic hormone-sensitive prostate cancer (mHSPC) a new treatment option,” says Professor, Outi Vaarala, Senior Vice President of Research and Development at Orion.

Darolutamide is approved in several markets around the world, including the U.S., the European Union (EU), Brazil, Canada and Japan, 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 by Bayer. The product is developed jointly by Orion and Bayer.

Photo of Outi Vaarala