Successful Phase III ARANOTE trial of darolutamide

German pharma major Bayer (BAYN: DE) and its partner, Finland’s Orion Corp (Nasdaq: OMX), today revealed that the Phase III ARANOTE trial met its primary endpoint, significantly increasing radiological progression-free survival (rPFS) with darolutamide + androgen deprivation therapy (ADT) compared to placebo plus ADT.

The safety data were comparable between both treatment arms and reconfirm the established tolerability profile of darolutamide in advanced prostate cancer.

Darolutamide is already approved 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, and patients with metastatic hormone-sensitive prostate cancer (mHSPC, in combination with ADT and docetaxel).