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
- In the Phase III ARANOTE trial, NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) demonstrated an improvement in radiological progression-free survival (rPFS) with a 46% statistically significant reduction in the risk of progression or death (HR 0.54; 95% CI 0.41-0.71; P<0.0001) compared to placebo plus ADT
- With these results, NUBEQA plus ADT now has demonstrated efficacy data in metastatic hormone-sensitive prostate cancer (mHSPC) both with and without docetaxel in the pivotal Phase III ARANOTE and ARASENS trials
- Results were consistent with the established safety profile of NUBEQA with no new safety signals observed
- ARANOTE results have been published simultaneously in The Journal of Clinical Oncology
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 The results were presented today as a late-breaking oral presentation at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, and published simultaneously in The Journal of Clinical Oncology.