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About NUBEQA® (darolutamide) in nmCRPC
For adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
For men with nmCRPC who are at high risk of developing metastatic disease, progression to mCRPC is a tipping point for increased suffering and mortality.
NUBEQA was the first NICE-recommended and SMC-accepted ARI in nmCRPC,* with proven efficacy, tolerability and a distinct molecular structure.
- Do current therapies help you achieve the treatment goals of men with nmCRPC?expand_moreDelay 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 vs. placebo+ ADT (secondary endpoint)*
Maintain your patient’s current lifestyleNUBEQA + ADT delivers:
- Discontinuation rate comparable to ADT (8.9% vs. 8.7%)
- The only ARI with <1% increase in treatment discontinuation when added to ADT in Phase 3 clinical trial
* At 3 years, the overall survival with NUBEQA + ADT was 83% (95% CI: 80 to 86) vs 77% (95% CI: 72 to 81) in the placebo group.
nmCRPC Checklist for NUBEQAYou can download the NUBEQA checklist for nmCRPC using the button below. - In high-risk nmCRPC, NUBEQA + ADT was investigated in ARAMIS, the largest Phase 3 study of an ARI of this patient population to dateexpand_more
ARAMIS was a double-blind, placebo-controlled, multi-centre study
* 73% of all patients had a Gleason score ≥7 at diagnosis.
- Clinically proven and recommended by NICE: Delay tumour progression and extend overall survival by >30% when adding NUBEQA to ADTexpand_more
NUBEQA's efficacy, supported by robust clinical data and extensive real-world evidence, is reflected in recommendations by NICE, acceptance by SMC, and inclusion in international guidelines.
In the Phase 3 ARAMIS trial, NUBEQA added to ADT significantly slowed tumor progression by 22 months and extended overall survival by >30% in patients with high-risk nmCRPC vs. ADT alone.
Median metastasis-free survival in men with high-risk nmCRPC (primary endpoint)
Adapted from Fizazi et al. 2019.
- NUBEQA + ADT more than doubled the median MFS vs. placebo + ADT (40.4 months vs. 18.4 months, HR: 0.41; 95% CI: 0.34–0.50; p<0.001).
Overall survival in men with nmCRPC (pre-specified final analysis)NUBEQA + ADT:31% reduced risk of deathvs. placebo + ADT (secondary endpoint)‡Adapted from Fizazi K et al. 2020.
- NUBEQA + ADT reduced the risk of death by 31% vs. placebo + ADT (secondary endpoint; HR: 0.69; 95% CI: 0.53–0.88; p=0.003; median OS not yet reached for either treatment arm)‡
- At 3 years, the overall survival with NUBEQA + ADT was 83% (95% CI: 80 to 86) vs 77% (95% CI: 72 to 81) in the placebo group
‡ ARAMIS trial. Men with high-risk nmCRPC. NUBEQA + ADT (n=955) vs. placebo + ADT (n=554). Primary endpoint was median MFS. Median MFS for NUBEQA + ADT was 40.4 months (n=955) vs. 18.4 months for placebo + ADT (n=554) (HR: 0.41; 95% CI: 0.34–0.50; p<0.001). 31.0% reduction in risk of death vs. ADT alone (HR: 0.69; 95% CI: 0.53–0.88; p=0.003); Number of patients with events 148/955 (15.5%) vs. 106/554 (19.1%) with placebo + ADT. Final analysis for OS was conducted after 254 deaths.
- NUBEQA + ADT significantly delayed the onset of cancer-associated morbidity and subsequent chemotherapy vs. ADT aloneexpand_more
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
NUBEQA + ADT offers 15 months longer without pain progression vs. placebo + ADT*ARAMIS: Key secondary and exploratory endpoints at 48 months in men with high-risk nmCRPC
Adapted from Fizazi K et al. 2019.
* ARAMIS trial. Men with nmCPRC. NUBEQA + ADT (n=955) vs. placebo + ADT (n=554). Primary endpoint was median MFS.
- Maintain your patient’s QoL with NUBEQA: The only ARI with <1% increase in treatment discontinuation when added to ADT in Phase 3 clinical trialexpand_more
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%).
High-risk nmCRPC‡Adapted from Fizazi K et al. 2019.
- Fatigue was the only AE to occur at an incidence of ≥10% with NUBEQA.
‡ ARAMIS trial. Men with high-risk nmCRPC. NUBEQA + ADT (n=955) vs. placebo + ADT (n=554). Primary endpoint was median MFS.
AEs of concern to people with high-risk nmCRPC were of similar incidence with NUBEQA + ADT and placebo + ADT*Adapted from Fizazi K et al. 2019.
- 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)
- 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%)
* ARAMIS trial. Men with high-risk nmCRPC. NUBEQA + ADT (n=955) vs. placebo + ADT (n=554). Primary endpoint was median MFS.
For the full list of AEs, please refer to theSummary of Product Characteristics.30.1% of patients remained on NUBEQA for ≥4 years†† ARAMIS Rollover study.
ADT: androgen deprivation therapy; AE: adverse event; AST: aspartate aminotransferase.
- Dosingexpand_more
Two 300 mg tablets, twice daily with food
Total daily dose 1200 mg. Administered without steroids
Renal impairment
- No dose adjustment is necessary for patients with mild or moderate renal impairment
- For patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m2) not receiving haemodialysis, the recommended starting dose is 300 mg twice daily
Hepatic impairment
- No dose adjustment is necessary for patients with mild hepatic impairment
- Available data on NUBEQA pharmacokinetics in moderate hepatic impairment is limited. NUBEQA has not been studied in patients with severe hepatic impairment. For patients with moderate and severe hepatic impairment (Child-Pugh Classes B and C), a starting dose of 300 mg twice daily is recommended
Elderly
- No dose adjustment is necessary in elderly patients
Paediatric populations
- There is no relevant use of darolutamide in the paediatric population
Missed doses
- If a dose is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose
- The patient should not take two doses together to make up for a missed dose
For more information about dosing modifications, missed doses, special warnings, precautions and interactions, please refer to the Summary of Product Characteristics.
* Apalutamide recommended by NICE in Oct 2021 and by SMC in Jul 2023.
PP-NUB-GB-1997 | February 2025
- Referencesexpand_more
- 1NUBEQA (darolutamide) Summary of Product Characteristics.
- 2Fizazi K et al. N Engl J Med. 2019;380(13):1235–1246.
- 3Fizazi K et al. N Engl J Med. 2020;383:1040–1049.
- 4NICE. Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer. ta104761. 2020. Available at: https://www.nice.org.uk/guidance/gid-ta10476/documents/final-appraisal-determination-document (last accessed January 2025).
- 5SMC. Medicines advice darolutamide. SMC2297. Available at: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-full-smc2297 (last accessed January 2025).
- 6Ito Y, Sadar MD. Res Rep Urol. 2018;10:23–32.
- 7Depuy V et al. Support Care Cancer. 2007;15:869–876.
- 8Gartrell BA, Saad F. Nat Rev Clin Oncol. 2014;11:335–345.
- 9Kirby M et al. Int J Clin Pract. 2011;65:1180–1192.
- 10McKay R et al. Prostate Cancer Prostatic Dis. 2017;20:276–282.
- 11Saad F et al. Prostate Cancer Prostatic Dis. 2017;20:110–116.
- 12Li TT et al. Cancer. 2017;123:3591–3601.
- 13Anantharaman A, Small EJ. Expert Rev Anticancer Ther. 2017;17(7):625–633.
- 14De Santis M, Steuber T. ESMO Open. 2019;4:e000484. doi:10.1136/esmoopen-2018-000484.
- 15Drudge-Coates L et al. Clin Genitourin Cancer. 2018;16(2):e411–e419.
- 16Hussain M et al. N Engl J Med. 2018;378(26):2465–2474.
- 17Smith MR et al. N Engl J Med. 2018;378(15):1408–1418.
- 18Shore ND, et al. Poster presented at American Urological Association Annual Meeting, April 2023. MP29-13.
- 19European Association of Urology (EAU) Guidelines. Prostate Cancer Treatment. 2024. Available at: https://uroweb.org/guidelines/prostate-cancer/chapter/treatment (last accessed January 2025).
- 20George DJ, et al. J Clin Oncol. 2023;41:332.
- 21NICE Guideline. Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer. Available at: https://www.nice.org.uk/guidance/ta740 (last accessed January 2025).
- 22Scottish Medicines Consortium (SMC) Guideline. nmCRPC: apalutamide (Erleada®), 2023. Available at: https://www.scottishmedicines.org.uk/medicines-advice/apalutamide-erleada-abbreviated-smc2579 (last accessed January 2025).