• Phase III study ARANOTE to be initiated in metastatic hormone-sensitive prostate cancer (mHSPC) assessing the androgen receptor inhibitor (ARi) in combination with standard androgen deprivation therapy (ADT)
  • Start of patient enrollment expected by the end of Q1 2021
  • Study adds to the robust development program for NUBEQA, exploring an opportunity to help even more patients with prostate cancer

San Francisco, CA (UroToday.com) — Bayer and Orion Corporation are expanding the global clinical development program for the oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide) in prostate cancer. A new Phase III study ARANOTE will investigate NUBEQA in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study builds on the robust development program comprising multiple studies, including the Phase III study ARASENS, which investigates NUBEQA combined with ADT and docetaxel compared to docetaxel and ADT alone in men with mHSPC.