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Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE)

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos

Videos

Press Release
Official Announcements on Clinical Developments
  • Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
  • Results were consistent with NUBEQA’s established safety profile with no new signals observed
  • NUBEQA now has positive mHSPC data both with and without docetaxel based on two pivotal Phase III studies
  • Bayer plans to present the pivotal data at a forthcoming scientific congress and discuss these data with the U.S. Food and Drug Administration (FDA) for regulatory approval

Reno, Nevada (UroToday.com) -- The Phase III ARANOTE trial, investigating NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of radiological progression-free survival (rPFS). NUBEQA plus ADT demonstrated a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT.
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Dayanand Sharma, MD, DNB,
Dr. Sharma presented the design of the ARANOTE trial, assessing darolutamide and androgen deprivation therapy (ADT), as compared to ADT alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).