Efficacy and safety of darolutamide in Black/African–American patients from the phase III ARAMIS study

Abstract

Aim: Darolutamide significantly improved metastasis-free survival (MFS) and overall survival (OS) versus placebo in the phase III ARAMIS study. We evaluated outcomes in Black/African–American patients in ARAMIS. Materials & methods: Patients with nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide (n = 955) or placebo (n = 554) plus androgen-deprivation therapy. The primary end point was MFS. Secondary end points included OS and safety. Results: In 52 (3.4%) Black/African–American patients, darolutamide improved MFS (median: not reached vs 12.4 months) and OS (3-year survival rates: 100 vs 71%) versus placebo. The safety profile of darolutamide in Black/African–American patients was consistent with that of all ARAMIS patients. Conclusion: In Black/African–American patients, darolutamide improved MFS and OS and was well tolerated, consistent with the overall ARAMIS population.