Conference Coverage
Conference Highlights Written by Physician-Scientist
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.
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
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.

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.

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).
Press Releases
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