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NUBEQA® (darolutamide)

Morbidity

In the phase 3 ARAMIS trial, the pre-specified final analysis showed that adding NUBEQA® to ADT significantly prolonged the time to each key secondary endpoint

  • Time to pain progression
  • Time to initiation of first chemotherapy
  • Time to first symptomatic skeletal event

Key secondary endpoints in the ARAMIS trial (pre-specified final analysis)

Key secondary endpoints in the ARAMIS trial (pre-specified final analysis)

Adapted from Fizazi et al. 2020.

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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.
     

  • Time to pain progression was evaluated using data from the primary analysis cut -off date of September3, 2018; data for time to initiation of chemotherapy and time to first symptomatic skeletal event are from the pre-specified final analysis (data cut-off November 15, 2019).

For further information, please refer to the Summary of Product Characteristics (SmPC) link below:

NUBEQA®(darolutamide) SmPC
NUBEQA® (darolutamide) | Dosing
Access information about NUBEQA dosing and administration.
PP-NUB-IE-0269-1, December 2025
NUBEQA® (darolutamide) | Safety
Discover more about NUBEQA's safety profile.
PP-NUB-IE-0268-1, December 2025
About NUBEQA® (darolutamide)
Access key information about NUBEQA® (darolutamide).
PP-NUB-IE-0264-1, December 2025

PP-NUB-IE-0267-1   |   December 2025

    Referencesexpand_less
    • 1
      Fizazi K et al. N Engl J Med. 2020;383:1040-9.
    • 2
      Fizazi K et al. N Engl J Med. 2019;380(13):1235–1246.