Addition of darolutamide to ADT, docetaxel extends survival in prostate cancer subset
The addition of darolutamide to docetaxel and androgen deprivation therapy significantly prolonged OS among men with metastatic hormone-sensitive prostate cancer, according to topline results of the randomized phase 3 ARASENS trial.
Darolutamide (Nubeqa, Bayer), an oral androgen receptor inhibitor, features a distinct chemical structure that competitively inhibits androgen binding, androgen receptor nuclear translocation and androgen receptor-mediated transcription.
The agent received FDA approval in July 2019 for treatment of men with nonmetastatic castration-resistant prostate cancer.
“For patients with [metastatic hormone-sensitive prostate cancer], there remains a significant need for new therapeutic approaches that improve treatment outcomes,” Scott Z. Fields, MD, senior vice president and head of oncology development at Bayer's pharmaceutical division, said in a company-issued press release. “ARASENS was prospectively designed to investigate whether combining Nubeqa with docetaxel and ADT could lead to an increase in overall survival for men with [metastatic hormone-sensitive prostate cancer].”
The multicenter, double-blind trial included 1,306 newly diagnosed men randomly assigned 1:1 to 600 mg darolutamide twice daily or matching placebo, in addition to standard-of-care docetaxel and ADT.
OS served as the primary endpoint. Secondary endpoints, all measured at 12-week intervals, included time to castration-resistant prostate cancer, time to start of subsequent anticancer therapy, time to first symptomatic skeletal event and time to pain progression. Researchers also assessed adverse events.
Results showed the combination significantly increased OS vs. docetaxel and ADT, according to the press release. Overall incidence of reported adverse events appeared similar between treatment arms.
Bayer plans to present detailed results of the study at an upcoming scientific congress.
Darolutamide also is being evaluated with ADT vs. placebo plus ADT among men with metastatic hormone-sensitive prostate cancer in the ongoing randomized phase 3 ARANOTE trial.