- Phase III ARASENS trial meets primary endpoint of overall survival for NUBEQA in combination with docetaxel and androgen deprivation therapy (ADT) versus docetaxel and ADT, a standard of care in men with metastatic hormone-sensitive prostate cancer (mHSPC)
- Bayer plans to present these pivotal data at a forthcoming scientific congress and discuss them with health authorities
- ARASENS is part of broad development program for NUBEQA, which includes another ongoing Phase III trial in mHSPC, ARANOTE, evaluating NUBEQA plus ADT
San Francisco, CA (UroToday.com) — 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, NUBEQA 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. NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).