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Clinical Trial
. 2022 Dec;18(40):4473-4482.
doi: 10.2217/fon-2022-0943. Epub 2023 Feb 8.

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

Neal D Shore  1 , Felipe Cruz  2 , Luke Nordquist  3 , Laurence Belkoff  4 , William J Aronson  5 , Bhupendra Tolia  6 , Arnold Cinman  7 , Roohollah Sharifi  8 , Jorge Ortiz  9 , Jacqueline Parkin  9 , Shankar Srinivasan  9 , Toni Sarapohja  10 , Matthew R Smith  11
Affiliations
Free article
Clinical Trial

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

Neal D Shore et al. Future Oncol. 2022 Dec.
Free article

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.

Keywords: African–American; androgen receptor antagonist; castration-resistant prostatic neoplasms; darolutamide; survival analyses.

Plain language summary

In patients with prostate cancer that has stopped responding to androgen-deprivation therapy, or ‘ADT,’ and has not spread 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.

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