The FDA approved darolutamide in July 2019 for the treatment of patients with nonmetastatic castration-resistant prostate cancer, based on findings from the phase 3 ARAMIS trial.
Neal D. Shore, MD, medical director of the Carolina Urologic Research Center, highlights the final overall survival (OS) analysis and crossover sub-analysis from the pivotal phase 3 ARAMIS trial in patients with nonmetastatic castration-resistant prostate cancer (CRPC). The crossover sub-analysis was presented in a poster during the 2021 Genitourinary Cancers Symposium (J Clin Oncol 39, 2021 [suppl 6; abstr 240]. doi: 10.1200/JCO.2021.39.6_suppl.240).
The FDA approved darolutamide (Nubeqa) in July 2019 for the treatment of patients with nonmetastatic CRPC, based on findings from the phase 3 ARAMIS trial. The double-blind trial included 1509 patients with nonmetastatic CRPC. Patients were randomized in a 2:1 ratio to receive oral darolutamide at 600 mg twice daily plus androgen deprivation therapy (ADT; n = 955) or placebo plus ADT (n = 554). Patients had an ECOG performance status of 0 to 1.
In the study, adding darolutamide to ADT reduced the risk of death by 31% compared with ADT plus placebo in men with nonmetastatic CRPC (HR, 0.69; P = .003). At a median follow-up of 29 months, the 3-year OS rates were 83% and 77% in the darolutamide and placebo arms, respectively.
This OS benefit was reached even though over half (55%) of the patients on the control arm received darolutamide (n = 170) or other subsequent treatments (docetaxel, abiraterone acetate [Zytiga], enzalutamide [Xtandi], sipuleucel-T [Provenge], and cabazitaxel [Jevtana]) after the study was unblinded.