Dr. Neal Shore on the final results and crossover analysis of pivotal darolutamide trial in nonmetastatic CRPC

Urology Times staff

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.