- NUBEQA® (darolutamide) is the first and only androgen receptor inhibitor (ARi) to show clinically meaningful delays in deterioration of important patient-relevant health-related quality of life (HRQoL) outcomes for patients with metastatic castration-sensitive prostate cancer (mCSPC)
- In post-hoc analyses of the Phase III ARANOTE trial, patients treated with NUBEQA plus androgen deprivation therapy (ADT) had an extended time to deterioration in HRQoL, with an additional 5.1 months compared to placebo plus ADT (16.6 months versus 11.5 months; HR 0.76, 95% CI 0.61–0.93)
- The results will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
NUBEQA extended the time to deterioration in the Functional Assessment of Cancer Therapy–Prostate (FACT-P) total score, a prespecified exploratory endpoint acting as a measure of overall well-being, by 5.1 months compared to placebo, with a median of 16.6 months versus 11.5 months (HR 0.76, 95% CI 0.61–0.93).1 Deteriorations in FACT-P subscales by ≥3 points were analyzed post hoc. The analysis showed that the clinically meaningful delay in deterioration of mCSPC patients HRQoL was driven by a longer time to deterioration in social and family well-being (HR 0.79, 95% CI 0.64–0.98), functional well-being (HR 0.78, 95% CI 0.63–0.96) and urinary symptoms (HR 0.78, 95% CI 0.61–0.99).1 NUBEQA also extended the time to pain progression compared to placebo (HR 0.72, 95% CI 0.54–0.96), as assessed using the Brief Pain Inventory-Short Form (BPI-SF) with pain progression defined as an increase of ≥2 points in BPI-SF worst pain score (WPS) observed at two consecutive evaluations or an initiation of opioid use for ≥7 consecutive days. Results were consistent with the established safety profile, with similar incidences of treatment-emergent adverse events versus placebo.1
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).2
Prostate cancer is the second most common cancer in men.3 Only 30% of those diagnosed with mCSPC will survive five years or more after diagnosis.4 Most people with mCSPC eventually progress to mCRPC, a condition with limited long-term survival.5,6
"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."- Alicia K. Morgans, M.D., Dana-Farber Cancer Institute, Boston
“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," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "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."
References:
- Morgans AK et al. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. Abstract 5004. Presented at ASCO 2025.
- NUBEQA® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023.
- Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834. Accessed: March 2025.
- Ng, K et al. Oncol Ther. 2020;8:209–230.
- Siegel DA et al. MMWR Morb Mortal Wkly Rep. 2020;69:1473–1480.
- Hahn AW et al. Am Soc Clin Oncol Educ Book. 2018 May 23;38:363-371.