Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy and Docetaxel in Black Patients From the Randomized ARASENS Trial.

In the ARASENS trial (NCT02799602), darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI, 0.57-0.80; P < .0001) compared with placebo plus ADT with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of darolutamide versus placebo in Black patients from ARASENS.


Patients with mHSPC were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. The primary endpoint was overall survival. Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety.

In ARASENS, 54 Black patients received darolutamide (n = 26) or placebo (n = 28) plus ADT and docetaxel. In Black patients, overall survival favored darolutamide versus placebo (median, not reached vs. 38.7 months; stratified HR, 0.41; 95% CI, 0.17-1.02), with 4-year survival rates of 62% versus 41%. The darolutamide group also had longer time to CRPC compared with the placebo group (median, not reached vs .12.6 months; HR, 0.09; 95% CI, 0.02-0.30). The safety profile of darolutamide in Black patients was consistent with that observed for the overall ARASENS population (grade 3/4 treatment-emergent adverse events, TEAEs: 61.5% vs. 66.1%; serious TEAEs: 42.3% vs. 44.8%).

In this small population of Black patients with mHSPC from the ARASENS trial, darolutamide was associated with an improvement in survival and time to CRPC and was well tolerated. Efficacy and safety findings in Black patients were consistent with the overall ARASENS population.

The oncologist. 2023 Oct 09 [Epub ahead of print]

Neal D Shore, Maha Hussain, Fred Saad, Karim Fizazi, Cora N Sternberg, David Crawford, Bertrand Tombal, Luke Nordquist, Michael Cookson, Frank Verholen, Jay Jhaveri, Shankar Srinivasan, Matthew R Smith

Carolina Urologic Research Center/Genesis Care, Myrtle Beach, SC, USA., Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA., Centre Hospitalier de l'Université de Montréal, University of Montreal, Montreal, Quebec, Canada., Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France., Englander Institute for Precision Medicine, Weill Cornell Department of Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York, NY, USA., University of California San Diego School of Medicine, San Diego, CA, USA., Division of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium., GU Research Network, Omaha, NE, USA., University of Oklahoma Stephenson Cancer Center, Oklahoma City, OK, USA., Bayer Consumer Care, Basel, Switzerland., Bayer Healthcare Pharmaceuticals, Inc., Whippany, NJ, USA., Massachusetts General Hospital Cancer Center, Boston, MA, USA.