NUBEQA® (darolutamide)
Overall Survival
NUBEQA® + ADT significantly improved overall survival vs. ADT alone
In the phase 3 ARAMIS trial, the pre-specified final overall survival analysis showed that NUBEQA + ADT significantly reduced the risk of death by 31% vs ADT alone (HR=0.69, 95% CI 0.53–0.88; p=0.003).
Overall survival in men with nmCRPC (pre-specified final analysis)
Adapted from Fizazi et al. 2020.
ARAMIS Study:
ARAMIS is a double-blind, randomised, placebo-controlled, multicentre phase 3 study in 1,509 nmCRPC patients with PSA doubling time of <10 months. Patients were randomised 2:1 to receive NUBEQA + ADT 600 mg bd (n=955) or placebo + ADT (n=554). The primary endpoint was metastasis-free survival. These data are from the pre-specified final OS analysis as OS data were not yet mature at the time of the MFS analysis.
PP-NUB-IE-0266-1 | December 2025