- 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.
Results were consistent with NUBEQA’s established safety profile with no new signals observed. Detailed results from this randomized, double-blind, placebo-controlled trial are planned to be presented at a forthcoming scientific congress.
NUBEQA is currently indicated in the U.S. for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1
"We are excited to share the positive results from this Phase III trial. Following potential regulatory approval, physicians will be able to tailor NUBEQA treatment plans with or without docetaxel based on individual patient’s needs. Today’s results build on the established efficacy and tolerability profile of NUBEQA. We are looking forward to future outcomes of our clinical development program investigating the compound across multiple prostate cancer stages and indications." - Christian Rommel, Ph.D. , Head of Research and Development at Bayer’s Pharmaceuticals DivisionBayer plans to present the pivotal data at a forthcoming scientific conference and discuss these data with the U.S. FDA regarding submission for regulatory approval.
References:
1. NUBEQA (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023.
Source: Bayer Corporation. (2024). Bayer Announces Positive Topline Results for NUBEQA® (Darolutamide) from Phase III Trial in Men with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) [Press release]. https://www.bayer.com/en/us/news-stories/phase-iii-trial-in-men-with-metastatic-hormone-sensitive-prostate-cancer.