Efficacy and safety of darolutamide in Black/African-American patients from the Phase III ARAMIS study
Future Oncology, our partner journal, has recently published a Short Communication Article, which provides information on the effect of darolutamide in the 52 Black/African-American patients who took part in the Phase III ARAMIS trial.
Abstract:
Background: 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 endpoint was MFS. Secondary endpoints 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.
Conclusions: In Black/African-American patients, darolutamide improved MFS and OS and was well tolerated, consistent with the overall ARAMIS population.
Lay Abstract:
In patients with prostate cancer that has stopped responding to androgen-deprivation therapy, or “ADT,” and is at risk of spreading to other parts of the body (known as nonmetastatic castration-resistant prostate cancer, or “nmCRPC”), darolutamide is an oral treatment option. Darolutamide added to ADT was tested in patients with nmCRPC in a large international study called ARAMIS and was found to prolong the time that patients were free from their cancer spreading compared with patients who received ADT alone. This report provides information on the effect of darolutamide in the 52 Black/African-American patients who took part in ARAMIS. In these patients, darolutamide showed similar effects on lowering the risk of their cancer spreading and was well tolerated.
Graphical Abstract:
