Phase III ARANOTE trial of darolutamide plus ADT meets primary endpoint in patients with mHSPC

The phase III ARANOTE trial found that darolutamide plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in metastatic hormone-sensitive prostate cancer (mHSPC) patients compared to placebo plus ADT. The safety profile was similar between treatment groups, confirming darolutamide's tolerability.

Approved as Nubeqa for non-metastatic castration-resistant prostate cancer (nmCRPC) and mHSPC (with ADT and docetaxel), darolutamide’s detailed ARANOTE results will be presented at a future congress, with Bayer planning global submissions to expand its use.

The trial involved 669 patients and assessed rPFS, overall survival, and other secondary endpoints. Prostate cancer, especially mHSPC, remains a significant concern, affecting many men worldwide.

Darolutamide, known for its low central nervous system penetration and minimal side effects, is approved in over 85 countries. Bayer and Orion Corporation developed it, and Bayer continues to focus on improving treatments for prostate cancer.