Key clinical point: Addition of darolutamide to androgen-deprivation therapy (ADT) significantly improved overall survival (OS) at 3 years in patients with nonmetastatic, castration-resistant prostate cancer (CRPC).
Major finding: The OS at 3 years significantly improved with darolutamide vs placebo (83% vs 77%; hazard ratio, 0.69; P =.003). No new safety signals were observed.
Study details: Final OS analysis of the phase 3 double-blind ARAMIS study: 1509 patients with nonmetastatic CRPC were randomly assigned to receive darolutamide plus ADT (n =955) or placebo plus ADT (n = 554).
Disclosures: The study was funded by Bayer HealthCare and Orion Pharma. I Kuss is an employee of and holds stock in Bayer; MA Le Berre and O Petrenciuc are employees of Bayer. T Sarapohja is an employee of Orion Pharma. A Snapir was previously employed by Orion Pharma. The remaining authors reported ties with various pharmaceutical companies, including Bayer and Orion Pharma.
“Use of androgen receptor blockade in patients with nonmetastatic, castrate-resistant prostate cancer where the doubling time of PSA is 10 months or less has become common place based on previous studies with surrogate endpoints. In this study, the authors report the overall survival and other secondary endpoint outcomes in patients fitting the above characteristics and were randomized to darolutamide versus placebo. Overall survival at 3 years was 83% in the group receiving darolutamide versus 77% in the group receiving placebo. A significant benefit with respect to other secondary endpoints, such as time to first use of cytotoxic therapy, was associated with use of darolutamide. No new safety signals were identified. This study is more evidence that the utilization of androgen receptor blockade in patients with nonmetastatic, castrate-resistant prostate cancer where the doubling time of PSA is 10 months or less is associated with clinical benefit.”
Mark Klein, MD
Fizazi K et al. N Engl J Med. 2020 Sep 10. doi: 10.1056/NEJMoa2001342.