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Darolutamide was well-tolerated by Black/African-American patients, and similar safety profiles were observed across the overall trial group.

Prostate cancer (PC) is the most common cancer among men in the United States (US) and is the world’s second most common cancer after lung cancer. Furthermore, PC is associated with a high incidence and mortality rate in Black and African-American men.

Darolutamide is an androgen receptor inhibitor (ARi) that has been shown to have a significant influence on PC. Darolutamide significantly enhanced metastasis-free survival (MFS) compared to placebo in the phase III ARAMIS investigation of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). The median MFS with darolutamide was 40.4 months, and for placebo it was 18.4 months. The study, which was published in the journal Future Oncology, focused on the results of Black/African-American patients in ARAMIS.

Patient Characteristics and Baseline Characteristics

In the ARAMIS trial, 52 Black/African-American patients were included, accounting for 3.4% of the overall study population. These patients were distributed across different geographic locations, with the United States and Brazil having the highest representation. With a few significant exceptions, demographic and baseline characteristics were broadly consistent with the whole ARAMIS sample. Moreover, Black/African-American patients who were treated with darolutamide reported a longer median time from diagnosis and a higher Eastern Cooperative Oncology Group (ECOG) performance status than the other populations.

Efficacy of Darolutamide

Initially, in Black/African–American patients, darolutamide showed a significant improvement in MFS over placebo. The median MFS was not reached in the darolutamide group, while it was 12.4 months in the placebo group. By the time the only event occurred in the darolutamide group, all placebo patients had discontinued the trial, and the hazard ratio could not be calculated.

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Overall Survival in the Darolutamide Group

At the final analysis data cut-off, darolutamide showed an overall survival (OS) benefit compared with placebo, with fewer deaths reported in the darolutamide group. Three-year OS rates were higher in the darolutamide group compared to the placebo group.

Secondary Efficacy Endpoints of Darolutamide

Darolutamide showed a longer time to first cytotoxic chemotherapy and median time to PSA progression than placebo. However, the low number of events in the Black/African-American population made it difficult to evaluate the time-to-pain progression.

Safety Profile of Darolutamide

Darolutamide’s safety profile in Black/African-American patients was consistent with that in other groups in the ARAMIS trial. Fewer adverse events and discontinuations due to adverse events were reported in the darolutamide group compared with the placebo group. The rates of grade 3/4 adverse events in Black/African-American patients were higher in the darolutamide group compared to the placebo group but consistent with those observed in the overall population.


Shore, N. D., Cruz, F., Nordquist, L., Belkoff, L., Aronson, W. J., Tolia, B., Cinman, A., Sharifi, R., Ortiz, J., Parkin, J., Srinivasan, S., Sarapohja, T., & Smith, M. R. (2022). Efficacy and safety of darolutamide in Black/African-American patients from the phase III ARAMIS study. Future Oncology (London, England), 18(40), 4473-4482. https://doi.org/10.2217/fon-2022-0943