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
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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ASCO GU 2022: A Randomized, Controlled, Phase 3 Study of Darolutamide in Addition to ADT Versus ADT Alone in Metastatic Hormone-Sensitive Prostate Cancer (ARANOTE)
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). Read More
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