About NUBEQA®▼ (darolutamide) in nmCRPC

Approved by NICE

Recommended as a treatment option for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease.

SMC accepted

For treatment of adult men with non-metastatic castration resistant prostate cancer who are at high risk of developing metastatic disease.

Do current therapies help you achieve the treatment goals of men with nmCRPC?

Delay metastasis and improve overall survival

^, 

NUBEQA + ADT delivers:

• 40.4 months MFS - more than double the median MFS vs ADT alone
• 31% reduced risk of death

Maintain your patient’s current lifestyle

NUBEQA + ADT delivers:

• Discontinuation rate comparable to ADT (8.9% vs. 8.7%)

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).

Adapted from Fizazi K et al. 2019. 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.

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

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).

Adapted from Fizazi et al. 2020. 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.

In the phase 3 ARAMIS trial, the pre-specified final analysis showed that adding NUBEQA to ADT was associated with benefits for all key secondary endpoints and significantly prolonged:

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

Adapted from Fizazi et al. 2020. 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).

In the phase 3 ARAMIS trial, there was no increase in discontinuation due to AEs with NUBEQA + ADT vs ADT alone (8.9% vs. 8.7%).

Adapted from Fizazi K et al. 2019. ARAMIS is a double-blind, randomised, placebo-controlled, multicentre phase 3 study in 1,509 nmCRPC patients with PSA doubling time of <10 months. The safety population included 954 patients in the NUBEQA + ADT group and 554 patients in the placebo + ADT group.

• The most frequently observed adverse reactions in patients receiving NUBEQA were fatigue/asthenic conditions (≥1/10) and rash, pain in the extremity, musculoskeletal pain, fractures, ischaemic heart disease and heart failure (≥1/100)
• Three laboratory test abnormalities were reported more frequently with NUBEQA + ADT than ADT:
  • Neutrophil count decreased (19.6% vs. 9.4%)
  • Bilirubin increased (16.4% vs. 6.9%)
  • AST increased (22.5% vs. 13.6%)
• With the exception of hypertension and urinary retention, there was very low incidence (<1%) of grade 3 or 4 AEs with NUBEQA + ADT
  • NUBEQA + ADT vs. ADT alone: Hypertension (3.1% vs. 2.2%); urinary retention (1.6% vs. 2.0%)
• With extended follow-up, the safety profile NUBEQA was favourable and consistent with the primary anaylsis

For the full list of AEs, please refer to the Summary of Product Characteristics.

ADT: androgen deprivation therapy; AE: adverse event; AST: aspartate aminotransferase.

Two 300 mg tablets, twice daily with food and water.

Total daily dose 1200 mg. Administered without steroids

• No dose adjustment is necessary for patients with mild or moderate renal impairment or mild hepatic impairment

For more information about dosing modifications, missed doses, special warnings, precautions and interactions, please refer to the Summary of Product Characteristics.