Abstract PR-07: Efficacy and safety of darolutamide in Black/African American patients from the phase III ARAMIS trial
Authors: Shore Neal , Cruz Felipe , Nordquist Luke , Belkoff Laurence , Aronson William , Tolia Bhupendra , Cinman Arnold , Sharifi Roohollah , Ortiz Jorge , Parkin Jacqueline , Srinivasan Shankar , Sarapohja Toni , Smith Matthew 
Published: January 2022

Abstract
Introduction and Objective: Higher incidence and mortality rates of prostate cancer (PC) have been observed in black and African-American men (B/AAs) compared with other racial and ethnic groups. B/AAs with PC are more likely to be diagnosed at a younger age with more extensive disease and exhibit differential gene expression associated with more aggressive disease, but they are less likely to receive therapy compared with white men. Darolutamide (DARO) is a structurally distinct and highly potent androgen receptor inhibitor. In the phase III ARAMIS trial, DARO significantly improved metastasis-free survival (MFS) and overall survival (OS) with a favorable safety profile in men with nonmetastatic castration-resistant prostate cancer (nmCRPC). We present the efficacy and safety of DARO in B/AAs from ARAMIS. Methods: Men with nmCRPC were randomized 2:1 to DARO (n=955) or placebo (PBO; n=554). The primary endpoint was MFS. Secondary endpoints included OS and time to first cytotoxic chemotherapy, prostate-specific antigen (PSA) progression, pain progression, and first symptomatic skeletal event (SSE). Adverse events (AEs) were assessed. Results: 52 B/AAs received DARO (n=28) or PBO (n=24) in ARAMIS. At baseline, the B/AA group treated with DARO had a median time from diagnosis of 101 months and 50% (n=14) had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 1; the median time from diagnosis in the entire DARO-treated population in ARAMIS was 86 months and 32% had ECOG PS of 1. At primary analysis data cutoff (3 Sept 2018), DARO improved MFS vs PBO (median: not reached vs 12.4 months) in the B/AAs group. At final analysis data cutoff (15 Nov 2019), 3-year OS rates were 100% (DARO) vs 71% (PBO). DARO showed longer time to first cytotoxic chemotherapy and PSA progression vs PBO. Time to pain progression and time to SSE were not evaluable due to the very low number of events. The safety profile of DARO in B/AAs was consistent with that observed for all patients. Fewer AEs (82% vs 92%) and discontinuations due to AEs (4% vs 17%) were reported with DARO vs PBO in the B/AA group. Conclusions: In this small population of B/AAs with nmCRPC, DARO was associated with an improvement in MFS, OS, and other secondary efficacy outcomes and was well tolerated. Efficacy and safety findings are consistent with the overall ARAMIS population.
Citation Format: Neal Shore, Felipe Cruz, Luke Nordquist, Laurence Belkoff, William Aronson, Bhupendra Tolia, Arnold Cinman, Roohollah Sharifi, Jorge Ortiz, Jacqueline Parkin, Shankar Srinivasan, Toni Sarapohja, Matthew Smith. Efficacy and safety of darolutamide in Black/African American patients from the phase III ARAMIS trial [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PR-07.