In ARASENS, risk of death was significantly reduced by 32.5% with darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0. 57-0.80; p < 0.001) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We assessed efficacy and safety of darolutamide in European patients from ARASENS.
Patients were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. Primary endpoint was overall survival. Secondary endpoints included time to metastatic castration-resistant prostate cancer (mCRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent systemic antineoplastic therapy, and safety.
In ARASENS, 472 (36%) patients were from Europe; 240 received darolutamide and 232 received placebo. Patient baseline characteristics were similar to those of the overall population. Darolutamide reduced the risk of death by 37% (HR, 0.63; 95% CI, 0.48-0.83), and delayed time to mCRPC, time to pain progression, time to first SSE, and time to initiation of subsequent systemic antineoplastic therapy compared with placebo. Incidences of serious treatment-emergent adverse events (TEAEs) were lower with darolutamide versus placebo (37.9% vs. 43.1%) compared with the overall population (44.8% vs. 42.3%).
In European patients with mHSPC, darolutamide improved overall survival and secondary endpoints including time to mCRPC and time to pain progression. Darolutamide was well tolerated with similar incidence of TEAEs between treatment groups. Efficacy and safety findings in European patients were consistent with the overall ARASENS population.
European journal of cancer (Oxford, England : 1990). 2026 Apr 05 [Epub ahead of print]
Bertrand Tombal, Maha Hussain, Fred Saad, Karim Fizazi, Neal Shore, Evgeny Kopyltsov, Martin Bögemann, Maria J Mendez-Vidal, Natasha Littleton, Shankar Srinivasan, Frank Verholen, Matthew R Smith
Division of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium. Electronic address: ., Northwestern University, Feinberg School of Medicine, Chicago, IL, USA., University of Montreal Hospital Center, Montreal, Quebec, Canada., Centre Oscar Lambret, Institut Gustave Roussy, University of Paris-Saclay, Lille, France., START Carolinas/Carolina Urologic Research Center, Myrtle Beach, SC, USA., Clinical Oncological Dispensary of Omsk Region, Omsk, Russian Federation., Department of Urology, Münster University Medical Center, Münster, Germany., Maimonides Institute for Biomedical Research of Cordoba, Reina Sofia University Hospital, Medical Oncology Department, Cordoba, Spain., Bayer Ltd., Dublin, Ireland., Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA., Bayer Consumer Care AG, Basel, Switzerland., Massachusetts General Hospital Cancer Center, Boston, MA, USA.