Transformative Evidence
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
Conference Coverage
Conference Highlights Written by Physician-Scientist
ASCO GU 2025: Darolutamide + ADT in Patients with mHSPC by Disease Volume: Subgroup Analysis of the Phase 3 ARANOTE Trial
Presented by Fred Saad, MD, FRCS
The 2025 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Fred Saad discussing a subgroup analysis of the phase 3 ARANOTE trial assessing darolutamide + ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume. Darolutamide + ADT significantly reduced the risk of radiological progression or death by 46% (HR 0.54, 95% CI 0.41–0.71; p < 0.0001) versus placebo plus ADT in patients with mHSPC in the ARANOTE trial. Read More
ESMO 2024: Invited Discussant: Phase 3 ARANOTE Trial, Phase 3 Evaluation of Transdermal Estradiol vs LHRH Agonists and Ancillary Study of the PEACE-1
Presented by Niven Mehra, MD
The 2024 ESMO annual meeting included a session on prostate cancer, featuring a discussion presentation by Dr. Niven Mehra discussing three abstracts including “Efficacy and safety of darolutamide plus ADT in patients with mHSPC from the phase 3 ARANOTE trial” by Dr. Fred Saad, “Prostate cancer efficacy results from a randomized phase 3 evaluation of transdermal estradiol versus LHRH agonists for androgen suppression in M0 prostate cancer” by Dr. Ruth Langley, and “Phenotypic and genomic characterization of de novo metastatic prostate cancer: an ancillary study of the PEACE-1 phase 3 trial” by Dr. Cedric Pobel. Read More
ESMO 2024 Late-Breaking Data: Phase III ARANOTE Trial Shows NUBEQA® (darolutamide) Significantly Reduced Risk of Radiological Progression or Death in Metastatic Hormone-Sensitive Prostate Cancer
Reno, Nevada (UroToday.com) -- Results from the investigational pivotal Phase III ARANOTE trial demonstrated that NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) showed a statistically significant and clinically meaningful improvement in radiological progression-free survival (rPFS) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 1 Read More
ESMO 2024: Efficacy and Safety of Darolutamide plus ADT in Patients with mHSPC from the Phase 3 ARANOTE Trial
Presented by Fred Saad, MD, FRCSC
(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Fred Saad discussing the efficacy and safety of darolutamide plus ADT in patients with mHSPC from the phase 3 ARANOTE trial. Eligible patients had mHSPC by conventional imaging, an ECOG performance status of 0–2, and started ADT ≤ 12 weeks. Read More
ESMO 2024: Bayer to Present New Prostate Cancer Data and Continued Oncology Portfolio Research at ESMO 2024
Bayer will present new oncology data, including a late-breaking, comprehensive analysis from the Phase III ARANOTE trial investigating NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), at the European Society for Medical Oncology (ESMO) Congress, taking place in Barcelona, Spain, from September 13-17, 2024.
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Press Releases
Official Announcements on Clinical Developments
Bayer Announces Positive Topline Results for NUBEQA® (Darolutamide) from Phase III Trial in Men with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- 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