- Bayer will present new data from the ARANOTE trial evaluating ultra-low prostate-specific antigen responses with NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT)
- Efficacy and safety results from an additional ARANOTE trial subgroup analysis in Black patients will be presented
- The company will present data on the long-term safety and tolerability of extended treatment with NUBEQA from the ARASENS Rollover trial and a North American subgroup analysis of the Darolutamide Observational (DAROL) trial
- Results from a U.S.-based quantitative survey on the challenges and unmet needs of caregivers of men with prostate cancer also will be presented
Reno, Nevada (UroToday.com) -- Bayer will present new data for NUBEQA® (darolutamide) in prostate cancer at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025. These data support the potential of NUBEQA as a treatment option across the prostate cancer disease spectrum and in diverse patient populations.
NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1
The company will present post-hoc analyses of ultra-low prostate-specific antigen (PSA) responses (<0.02 ng/mL) and the correlation of ultra-low PSA responses with clinical outcomes from the Phase III ARANOTE trial evaluating NUBEQA and androgen deprivation therapy (ADT) in mHSPC.
An additional ARANOTE analysis on the efficacy and safety of NUBEQA plus ADT in Black men with mHSPC will be presented.
Additionally, data from the Phase III ARASENS Rollover trial evaluating the long-term safety and tolerability benefit of extended treatment with NUBEQA will be presented.
Other key data to be presented include the North American subgroup analysis from the third interim analysis of the Darolutamide Observational (DAROL) trial evaluating the safety and efficacy of NUBEQA in a real-world setting in patients with nmCRPC, and an update on the in progress Phase III ARASTEP trial, evaluating NUBEQA plus ADT in patients with high-risk biochemical recurrence.
A separate presentation will highlight results from a U.S.-based quantitative survey on the challenges and unmet needs of caregivers of men with prostate cancer.
Details on selected abstracts from Bayer at the AUA 2025 Annual Meeting follow:
NUBEQA (darolutamide):
- • Ultra-low PSA Response (<0.02 ng/mL) with Darolutamide Plus ADT in ARANOTE Correlates with Greatly Improved Clinical Outcomes
- Interactive Poster Session: IP26-07; April 29, 9:30-11:30 a.m. PDT
- Efficacy and Safety of Darolutamide Plus Androgen-Deprivation Therapy (ADT) in Black Patients with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) from the Phase 3 ARANOTE Trial
- Moderated Poster: MP16-01; April 27, 1:00-3:00 p.m. PDT
- Long-Term Safety and Tolerability of Extended Treatment with Darolutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Insights from ARASENS Rollover Study
- Interactive Poster: IP26-06; April 29, 9:30-11:30 a.m. PDT
- Prespecified Third Interim Analysis of the Darolutamide Observational (DAROL) Study in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): North American (NAm) Subgroup Analysis
- Interactive Poster: IP26-25; April 29, 9:30-11:30 a.m. PDT
- Darolutamide Plus Androgen-Deprivation Therapy (ADT) in Patients with High-Risk Biochemical Recurrence (BCR) of Prostate Cancer: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ARASTEP)
- Clinical Trials in Progress Presentation: April 28, 2:44- 2:52 p.m. PDT
- Challenges and Unmet Needs of Caregivers for Patients with Prostate Cancer: A US-based Quantitative Survey
- Abstract IP04-31; April 26, 9:30-11:30 a.m. PDT