Key takeaways
Quality of life metrics matter in mCSPC trials: Post-hoc ARANOTE data shows that Nubeqa + ADT significantly delays deterioration in HRQoL, including social, functional, and urinary well-being—highlighting the value of incorporating patient-reported outcomes into protocol design and endpoint strategy.
Pain progression as a differentiator: The combination therapy delayed pain progression compared to placebo, reinforcing the importance of including validated pain assessments (e.g., BPI-SF) in clinical trials for metastatic prostate cancer.
Consistent safety profile supports broader application: The safety data remains consistent with previous studies (e.g., ARASENS), which may support more streamlined safety monitoring processes and risk mitigation planning for similar studies.
Bayer has shared data from a new post-hoc analysis of the Phase III ARANOTE clinical trial (NCT04736199) evaluating Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic castration-sensitive prostate cancer (mCSPC). Latest results from the study show patients treated with the Nubeqa-ADT combination experienced a clinically meaningful improvement in health-related quality of life (HRQoL) and delayed pain progression. This new data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.1
Delayed functional decline highlighted by FACT-P score
Further results show Nubeqa extended the time to deterioration in the Functional Assessment of Cancer Therapy–Prostate (FACT-P) total score by 5.1 months, with a median of 16.6 months versus 11.5 months. This is an exploratory endpoint in ARANOTE which acted as a measure of overall well-being. The post-hoc analysis found that the clinically meaningful delay in deterioration of mCSPC patients’ HRQoL was attributed to a longer time to deterioration in social and family well-being, functional well-being, and urinary symptoms.
In a press release, Alicia K. Morgans, MD, Dana-Farber Cancer Institute, Boston, said: "These results from the ARANOTE trial highlight the potential of darolutamide to not only extend radiographic progression-free survival for patients with metastatic castration-sensitive prostate cancer, but to do so while creating clinically meaningful delays in deterioration of quality of life compared to ADT alone. The ability to maintain social, family, and functional well-being, along with managing urinary symptoms and delaying pain progression, are important to patients with metastatic castration-sensitive prostate cancer."
As mentioned by Morgans, the Nubeqa-ADT combination also extended time to pain progression compared to placebo, as assessed by the Brief Pain Inventory-Short Form (BPI-SF). Results from this new analysis were consistent with the established safety profile of Nubeqa.
ARANOTE trial design and key endpoints
ARANOTE is a randomized, double-blind, placebo-controlled study. The trial had 669 participants that were randomized to receive 600 mg of Nubeqa twice daily or matching placebo in addition to ADT. Secondary endpoints of the study include overall survival (OS), time from randomization to the date of death from any cause, and time from randomization to the date of first castration-resistant event.2
In the press release, Christine Roth, executive vice president, global product strategy and commercialization and member of the Pharmaceuticals Leadership team at Bayer, added: “These findings underscore the ability of Nubeqa to extend radiographic progression free survival and support quality of life for patients facing metastatic castration-sensitive prostate cancer. These results reflect our unwavering commitment to redefining prostate cancer care and enhancing patient outcomes at various stages of the disease. By focusing on innovative therapies that address the comprehensive needs of cancer patients, we aim to improve their overall treatment experience."
ARASENS trial previously supported Nubeqa approval
In August 2022, the FDA approved Nubeqa alongside docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The approval was based on positive results from the Phase III ARASENS trial (NCT02799602), which compared the efficacy of Nubeqa plus ADT and docetaxel to ADT and docetaxel.3
ARASENS demonstrated a statistically significant increase in the trial’s primary endpoint of OS with a reduction in the risk of death by 32% for those in the Nubeqa treatment arm. The Nubeqa plus ADT and docetaxel treatment also achieved a statistically significant delay in time to pain progression.
In the randomized, double-blind, placebo-controlled, multicenter ARASENS study, a total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of Nubeqa twice a day or matching placebo, plus ADT and 75 mg/m2 of docetaxel, for 6 cycles.4
References
1. ASCO 2025: Phase III ARANOTE Post-hoc Analyses Presented on Health-Related Quality of Life and Pain Outcomes in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving NUBEQA® (darolutamide) plus ADT. News release. Bayer. May 27, 2025. Accessed May 27, 2025. https://www.businesswire.com/news/home/20250523155874/en/ASCO-2025-Phase-III-ARANOTE-Post-hoc-Analyses-Presented-on-Health-Related-Quality-of-Life-and-Pain-Outcomes-in-Patients-with-Metastatic-Castration-Sensitive-Prostate-Cancer-Receiving-NUBEQA-darolutamide-plus-ADT
2. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). ClinicalTrials.gov. Accessed May 27, 2025. https://clinicaltrials.gov/study/NCT04736199
3. U.S. FDA Approves Additional Indication of NUBEQA® (darolutamide) in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). News release. Bayer. August 5, 2022. Accessed May 27, 2025. https://www.businesswire.com/news/home/20220805005477/en/U.S.-FDA-Approves-Additional-Indication-of-NUBEQA-darolutamide-in-Combination-with-Docetaxel-for-the-Treatment-of-Metastatic-Hormone-Sensitive-Prostate-Cancer-mHSPC
4. Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (ARASENS). ClinicalTrials.gov. Accessed May 27, 2025. https://clinicaltrials.gov/study/NCT02799602
