Darolutamide in Black Men With mHSPC: Insights From the ARANOTE Trial
Quoc-Dien Trinh, MD, MBA, discusses a sub-analysis of the phase 3 ARANOTE trial, which focused on Black patients with metastatic hormone-sensitive prostate cancer.
Quoc-Dien Trinh, MD, MBA, Chair of the Department of Urology, University of Pittsburgh School of Medicine, and Chair of Urology, UPMC, discusses a sub-analysis of the phase 3 ARANOTE trial (NCT04736199), which focused on Black patients with metastatic hormone-sensitive prostate cancer (mHSPC). Specifically, he shares how these findings contribute to the understanding of the potential benefits of darolutamide (Nubeqa) given the historical disparities in prostate cancer outcomes for Black men.
The ARANOTE trial evaluated the efficacy and safety of adding darolutamide to androgen-deprivation therapy (ADT) in men with mHSPC. Among the 669 patients, about 10% self-identified as Black—a group historically burdened with disproportionately poor prostate cancer outcomes.
The study found that the addition of darolutamide significantly improved radiographic progression-free survival (rPFS) in the overall population (hazard ratio [HR] 0.54), and this benefit extended to Black patients, who had a comparable HR of 0.51. Similarly, the time to development of metastatic castration-resistant prostate cancer (mCRPC) was delayed in both groups.
“We know that Black men are more likely to develop prostate cancer but also to die from prostate cancer. So it is very reassuring to know that in this sub-population, the outcomes, the efficacy of this drug, were certainly similar, and perhaps some signal that it could be even more beneficial,” he shares.
A particularly notable finding was that nearly 60% of Black men receiving darolutamide achieved PSA suppression below 0.2 ng/mL, compared with under 20% in those receiving ADT alone—a strong indicator of treatment efficacy.
Safety outcomes for Black participants were consistent with the broader trial population, though a potential increase in hypertension was noted, possibly due to preexisting risk factors. Importantly, the tolerability was high, with no significant differences in treatment discontinuation rates between groups.
“There is a lot of real-world evidence suggesting that underserved populations are less likely to get the latest therapies, sometimes more likely to get ADT alone, and sometimes the conversations and the things we may hear pertain to the fact that perhaps doublet therapy. The intensification leads to potentially more [adverse] effects, and assessing the safety of this drug in this population is important.”
“The message to clinicians and to patients is that treatment intensification with darolutamide is certainly something that should be strongly considered in light of our sub-study,” he adds.
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