Comparing the safety profile of darolutamide with other androgen receptor inhibitors in Black patients

EP: 1.The Incidence of Prostate Cancer and Risk of Progression in Black Men

EP: 2.Factors Contributing to Higher Incidence and Worse Outcomes of mHSPC in Black Men

EP: 3.Representation of Black men with mHSPC in clinical trials

EP: 4.The current treatment landscape of mHSPC

EP: 5.Efficacy outcomes in Black patients from the ARANOTE trial

EP: 6.Safety data on Black patients from ARANOTE

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EP: 7.Comparing the safety profile of darolutamide with other androgen receptor inhibitors in Black patients

EP: 8.Outcomes in Black patients receiving darolutamide plus ADT for mHSPC

EP: 9.Translating the Trial: How Findings from ARANOTE May Inform Treatment Decisions

EP: 10.The importance of studying efficacy and safety of treatment in Black patients with mHSPC

EP: 11.Improving diversity in future clinical trials for mHSPC

EP: 12.Remaining unmet needs in diverse populations with mHSPC

Safety Data from Multiple Sources

Key Themes:

• The ARANOTE study had sufficient Black male representation for meaningful comparative analysis.
• Safety data from other clinical trials show similar patterns.
• Real-world evidence corroborates safety in Black men.
• This category of drugs (androgen receptor antagonists) appears generally safe across racial groups.

Key Points for Physicians:

• Multiple data sources support the safety of darolutamide in Black men.
• Real-world evidence complements clinical trial findings.
• Specific subanalysis provides higher confidence in safety conclusions.

Notable Insights: The convergence of evidence from clinical trials and real-world data strengthens confidence in safety conclusions despite relatively small sample sizes in individual studies.

Clinical Significance: The combination of clinical trial data and real-world evidence provides a comprehensive safety profile supporting the use of darolutamide in Black men with metastatic hormone-sensitive prostate cancer.