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NUBEQA® (darolutamide)

Metastasis Free Survival

NUBEQA + ADT more than doubled median MFS vs ADT

In the phase 3 ARAMIS trial, NUBEQA + ADT significantly extended median MFS by 22 months vs ADT (40.4 months vs. 18.4 months, HR: 0.41; 95% CI:0.34–0.50; p<0.001).

Median MFS in men with nmCRPC (primary endpoint)

Median MFS in men with nmCRPC (primary endpoint)

Adapted from Fizazi K et al. 2019. 

Patient Image - Nubeqa

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. The planned primary analysis was performed after 437 primary end-point events had occurred.

Abbreviations:

ADT, androgen deprivation therapy; bd, twice daily; MFS, Metastasis Free Survival; nmCRPC, non-metastatic castration-resistant prostate cancer; PSA, prostate-specific antigen.

PP-NUB-IE-0265-1   |   December 2025

    • 1
      NUBEQA® (darolutamide) Summary of Product Characteristics.
    • 2
      Fizazi K et al. N Engl J Med. 2019;380(13):1235–1246.