- (PLX AI) - Bayer Phase III trial with Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy meets primary endpoint of significantly increasing overall survival in patients with metastatic hormone-sensitive prostate cancer.
- • Says trial demonstrates an increase in overall survival evaluating darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) compared to docetaxel and ADT, a standard of care in metastatic hormone-sensitive prostate cancer (mHSPC)
- • Bayer plans to present these pivotal data at a forthcoming scientific congress and to discuss them with health authorities
- • ARASENS is part of broad development program for darolutamide which includes another ongoing Phase III trial in mHSPC, ARANOTE, evaluating darolutamide plus ADT
- • 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