Pre-specified final survival analysis of phase III ARAMIS trial of darolutamide plus androgen deprivation therapy (ADT) shows statistically significant improvement in overall survival in non-metastatic castration-resistant prostate cancer

In RCT (n=1509), addition of darolutamide, an androgen receptor inhibitor, to ADT was linked to a statistically significant improvement in the secondary endpoint of overall survival compared to ADT alone, with a 31% reduction in risk of death (HR 0.69, 95% CI 0.53-0.88; p=0.003)

SPS commentary:

Previously published results demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival (median of 40.4 vs. 18.4 months with ADT alone, p<0.001), however overall survival data were not yet mature at the time of that analysis.


Darolutamide is licensed for the treatment of adult men with non-metastatic castration resistant prostate cancer who are at high risk of developing metastatic disease. Its approval in the U.S and EU were based on the ARAMIS trial data.


Biospace Inc.