Dr Trinh on Outcomes for Darolutamide Plus ADT in Black Patients With mHSPC

The implications of these findings is that we need to strongly consider treatment intensification in all populations based on these data and specifically in the Black population."

Quoc-Dien Trinh, MD, MBA, chair of the Department of Urology at the University of Pittsburgh School of Medicine and UPMC, discussed the clinical implications of outcomes for Black patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with darolutamide (Nubequa) plus androgen deprivation therapy (ADT) in the phase 3 ARANOTE trial (NCT04736199).

Darolutamide is a second-generation androgen receptor inhibitor designed to bind directly to the androgen receptor. Prior findings from ARANOTE supported the submission of a supplemental new drug application to the FDA seeking the approval of darolutamide in combination with ADT for the treatment of patients with mHSPC.

According to Trinh, the subgroup analysis of Black patients treated during the ARANOTE trial demonstrated that darolutamide plus ADT (n = 41) reduced the risk of radiographic progression or death by 49% compared with placebo plus ADT (n = 24; HR, 0.51; 95% CI, 0.21-1.23). Median radiographic progression-free survival (rPFS) was not reached in either treatment arm, and the rPFS benefit appeared consistent across prespecified clinical subgroups, despite small sample sizes. Trinh emphasized that these findings strongly support the need for treatment intensification strategies across all patient populations, including Black patients, who have historically been underrepresented in clinical research.

Additional efficacy measures showed that patients receiving darolutamide plus ADT achieved higher rates of prostate-specific antigen (PSA) responses (<0.2 ng/mL) and delayed time to PSA progression compared with those receiving placebo plus ADT. The safety profile of darolutamide was favorable and consistent with the overall ARANOTE population, with no new safety concerns observed.

Trinh highlighted that patients, particularly from underserved populations, should be encouraged to advocate for evidence-based treatment options. He stressed that clinicians must integrate emerging data that specifically evaluate outcomes in diverse populations into routine decision-making processes to ensure equitable care.

Potential future directions include continued efforts to validate darolutamide’s benefits in real-world settings and to design prospective trials that specifically enrich for diverse patient populations, Trinh concluded.