Darolutamide benefit demonstrated in Black patients with nmCRPC

An analysis from the phase 3 ARAMIS trial found that the efficacy of darolutamide (Nubeqa) in Black/African American (B/AA) patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) was similar to that in the overall trial population.1

These results were reported at the 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved.

“Compared with other racial and ethnic groups, Black/African American individuals have disproportionately higher rates of prostate cancer incidence and mortality. Despite this disparity, many clinical trials of prostate cancer therapies fail to publish demographic information on race and ethnicity,” explained presenter and co-author Neal D. Shore, MD, in a news release.2

Overall, the double-blind ARAMIS trial included 1509 patients with nmCRPC. Patients were randomized in a 2:1 ratio to receive oral darolutamide at 600 mg twice daily plus androgen deprivation therapy (ADT; n = 955) or placebo plus ADT (n = 554). Patients had an ECOG performance status of 0 to 1. The primary end point of the trial was metastasis-free survival (MFS), with overall survival (OS) as the key secondary end point.

In the overall study population, the median MFS was 40.4 months in the darolutamide cohort and 18.4 months in the placebo cohort, translating to a 59% reduction in the risk of metastases or death (HR, 0.41; P <.001). At a median follow-up of 29 months, the 3-year OS rates were 83% versus 77%, respectively, translating to a 31% reduction in the risk of death (HR, 0.69; P = .003).3 The darolutamide regimen also led to statistically significant delays in the time to first symptomatic skeletal event (SSE; HR, 0.48; P = .005), time to pain progression (HR, 0.65; P <.0001), and time to initiation of cytotoxic chemotherapy (HR, 0.58; P <.0001).

The analysis presented at the AACR cancer disparities conference included 52 B/AA patients, 28 of whom were treated with and 24 were given the placebo. When comparing the B/AA population to the overall study population, the median time from diagnosis for B/AA patients treated with darolutamide was 101 months versus 86 months in the overall darolutamide-treated group. The percentage of patients with an ECOG performance status of 1 was 50% versus 32%, respectively.

Results showed that B/AA patients who received darolutamide had a longer period of MFS than B/AA patients who received placebo (median: not reached vs 12.4 months, respectively). Similarly, 3-year OS rates favored darolutamide at 100% versus 71%, respectively.

Safety data for the B/AA population were consistent with the overall study population. The incidence of adverse events (AEs) across all grades in the B/AA population was 82% with darolutamide versus 92% in the control arm. The rates of AE-related discontinuation were 4% versus 17%, respectively. The times to first cytotoxic chemotherapy and PSA progression were also lower with darolutamide. Due to the low number of events, time to pain progression and time to SSE could not be evaluated in this study.

“Our study provides important findings that help to address the lack of data in Black/African American patients who are disproportionally affected by prostate cancer. Additional research is warranted to better understand the disparity in outcomes in these patients and help guide treatment choices tailored to their individualized health care needs,” said Shore. “In future clinical trials, we need to improve participation of underrepresented populations through such efforts as building trust in the health care system, utilizing patient advocates, and increasing awareness and educational opportunities.”


1. Fizazi K, Shore ND, Tammela T, et al. Efficacy and safety of darolutamide in Black/African American patients from the phase III ARAMIS trial. Paper presented at: 14th AACR Conferenence on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; October 6-8, 2021; virtual.

2. Darolutamide Showed similar benefits for Black/African American patients as observed in the overall population of the ARAMIS trial. Published online October 6, 2021. Accessed October 6, 2021. https://www.eurekalert.org/news-releases/930247.

3. Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med. 2020;383(11):1040-1049. doi: 10.1056/NEJMoa2001342