Darolutamide Demonstrates Superior Benefits in Black and White Patients with Non-Metastatic Prostate Cancer
Key Insights
Real-world evidence from the DEAR study (search) reveals darolutamide offers longer treatment duration and delayed progression compared to enzalutamide and apalutamide in non-metastatic castration-resistant prostate cancer (search) patients.
Among 1,205 patients studied, darolutamide showed lower discontinuation rates (32.8% Black, 37.9% White) compared to enzalutamide (44.8% Black, 53.1% White) and apalutamide (48.8% Black, 50.4% White).
Median metastasis-free survival was not reached in the darolutamide group for both racial cohorts, while enzalutamide and apalutamide groups showed shorter survival periods.
New real-world evidence suggests darolutamide provides superior clinical benefits compared to enzalutamide and apalutamide in both Black and White patients with non-metastatic castration-resistant prostate cancer (search) (nmCRPC). The findings were presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco.
Study Design and Patient Demographics
The research, led by Dr. Daniel J. George from Duke Cancer Center (search), analyzed data from 1,205 patients, including 282 Black and 923 White participants. The treatment distribution was consistent across both racial cohorts, with 41% receiving darolutamide, 44% receiving enzalutamide, and 15% receiving apalutamide. Patients initiated treatment between August 2019 and March 2023.
Treatment Outcomes and Discontinuation Rates
The study revealed significant differences in treatment discontinuation rates. Darolutamide demonstrated notably lower discontinuation rates in both racial groups:
- Black patients: 32.8% for darolutamide vs. 44.8% for enzalutamide and 48.8% for apalutamide
- White patients: 37.9% for darolutamide vs. 53.1% for enzalutamide and 50.4% for apalutamide
While the median time to discontinuation was not reached in the darolutamide group for either racial cohort, enzalutamide and apalutamide groups showed shorter duration:
- Black patients: 25.5 months for enzalutamide and 29.0 months for apalutamide
- White patients: 26.1 months for enzalutamide and 25.7 months for apalutamide
Metastasis-Free Survival Analysis
The metastasis-free survival (MFS) data further supported darolutamide's superior performance. During the study period, 32.3% of Black patients and 42.3% of White patients experienced an MFS event. Notably, median MFS was not reached in the darolutamide group for either racial cohort.
For Black patients, median MFS was 47.7 months in the enzalutamide group and 34.5 months in the apalutamide group. White patients showed median MFS of 29.2 months for enzalutamide and 32.2 months for apalutamide.
Safety and Tolerability
Treatment-emergent adverse events were among the primary reasons for discontinuation across all groups. However, these events occurred less frequently in patients receiving darolutamide compared to those on enzalutamide or apalutamide, indicating a more favorable safety profile.
Clinical Implications
These findings build upon previous results from the DEAR study (search) (NCT05362149) and its extension DEAR-EXT (search) (NCT06013475), providing robust evidence for darolutamide's effectiveness in nmCRPC treatment. The consistent benefits observed across racial cohorts suggest darolutamide may be a preferred treatment option for both Black and White patients with nmCRPC.