Identifying the right patient
for triplet therapy
Use NUBEQA®, the only ARPI with Swissmedic approval** and reimbursement# by the health insurance company in the triplet setting(3)
** Swissmedic approval without volume/risk restriction: NUBEQA®, in combination with docetaxel and ADT, is indicated for the treatment of adult patients with mHSPC for whom docetaxel therapy is indicated.3
# Extract from the specialty list: NUBEQA®, in combination with docetaxel and ADT, is reimbursed for the treatment of adult patients with highvolume/high-risk mHSPC for whom docetaxel therapy is indicated (ECOG PS ≤1). 6
ARPI = androgen receptor pathway inhibitor
The results support the use of darolutamide in combination with ADT and docetaxel in all patients with mHSPC, regardless of age13
Offer to your mHSPC patients strong efficacy thanks to the combined power of Nubeqa + docetaxel + ADT
// Global, randomized, double-blind, placebo-controlled phase 3 study (NCT02799602)1,2
// The primary analysis was conducted after 533 deaths
// Secondary efficacy endpoints were tested hierarchically
*Starting ≤6 weeks after start of study drug at 75 mg/m2 / 3 weeks, 6 cycles (in combination with prednisone/prednisolone at the discretion of the investigator).
#Investigators’ choice (including orchiectomy) starting ≤12 weeks before randomization
†One enrolled patient was excluded from all analysis sets because of Good Clinical Practice violations.
‡One patient randomized to the placebo group but who received darolutamide was included in the placebo group for the full analysis set and in the darolutamide group for the safety analysis set.
5. Smith M, et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer N Engl J Med. 2022; DOI: 10.1056/NEJMoa2119115. 2. ClinicalTrials.gov identifier: NCT0279960. Accessed January 2022. https://clinicaltrials.gov/ct2/show/NCT02799602.
Endpoints
Primary:
// Overall survival (OS)
Secondary:
// Time to castration-resistant prostate cancer
// Time to pain progression
// Symptomatic skeletal event-free survival (SSE-FS)
// Time to first symptomatic skeletal evemt (SSE)
// Time to initiation of subsequent antineoplastic therapy
// Time to worsening of physical symptoms of disease
// Time to initiation of opioid use for ≥7 consecutive days
// Safety
When intensifying treatment for patients with metastatic hormone-sensitive prostate cancer (mHSPC), it is essential to consider multiple factors related to the patient, tumour, and metastasis characteristics.1
Triplet therapy with Nubeqa
Patients with high-volume and de novo metastatic hormone-sensitive prostate cancer can benefit from triplet therapy when their individual circumstances are taken into account, highlighting the importance of a personalized treatment approach.1
Green – no restrictions for concurrent administration
Yellow – with caution, dose adjustment may be necessary
Red – contraindication / avoid / consider therapy adjustment
DOWNLOAD PUBLICATION§
Androgen receptor pathway inhibitors and drug-drug interactions in prostate cancer von ESMO Open Review§,9
provides additional information that, alongside the product information and other scientific literature, helps to quickly identify potential drug interactions.
ADT: Androgen-Deprivationstherapie; ARPIs: Androgen Receptor Pathway Inhibitors
Daro: Darolutamid; Abi: Abirateron; Apa: Apalutamid; Enza: Enzalutamid; Tz: Thrombozyten, CV: cardiovascular
* The following tables include medications that are most commonly found in patients undergoing treatment for prostate cancer; this list is not exhaustive.
For further information, please consult the respective product information.
§ We would like to bring to your attention that the following link leads to an external page. Bayer (Schweiz) AG has no influence on the design and content of the linked page and therefore expressly disclaims any responsibility for the content of external pages and the resulting consequences.
Evaluating Drug-Drug-Interactions – supporting material
mHSPC patients may already be on other medications due to comorbidities. This scheme will help you to assess the drug interaction with ARPIs.
Hit early. Hit hard. Think NUBEQA®.
Nubeqa® - Built for the long term 14
Swiss Consensus Recommendations
A majority (60%) of the Swiss Consensus Board of SAKK recommends for high volume mHSPC patients a triplet
with ADT + docetaxel + ARPI.
ADT: androgen deprivation therapy, ARPI: androgen receptor pathway inhibitor
* In the overall population, the primary endpoint of overall survival was achieved with triplet therapy compared to docetaxel and ADT alone: HR: 0.675; 95% CI: 0.568–0.801; p<0.0001. The secondary endpoint related to time to CRPC compared to docetaxel and ADT alone: HR: 0.357; 95% CI: 0.302–0.421; p<0.0001. (4)
References:
- Templeton AJ, et al. Interdisciplinary Swiss consensus recommendations on staging and treatment of advanced prostate cancer. Swiss Med Wkly 2023;153:40108.
- Hoeh B, et al. Triplet or Doublet Therapy in Metastatic Hormone-sensitive Prostate Cancer: Updated Network Meta-analysis Stratified by Disease Volume. Eur Urol Focus 2023;9(5):838–842.
- Swiss specialist information NUBEQA ® , www.swissmedicinfo.ch, As of 07/24.
- Hussain M, et al. Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial. J Clin Oncol 2023;41(20):3595–3607.
- Smith MR, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med 2022;386:1132–1142.
- FOPH specialty list, www.spezialitaetenliste.ch, last accessed March 2025.
- Turco F et al. Safety profile of darolutamide versus placebo: a systematic review and meta-analysis. Prostate Cancer Prostatic Dis 2024 Sep;27(3):385-392.
- Fachinformation Schweiz Zytiga (Arbirateron): www.swissmedicinfo.ch
- Bolek H, et al. Androgen receptor pathway inhibitors and drug-drug interactions in prostate cancer. ESMO Open 2024;9(11):103736.
- Bourjonnier F et al. Pharmacokinetic Interactions Between Abiraterone, Apalutamide, Darolutamide or Enzalutamide and Antithrombotic Drugs: Prediction of Clinical Events and Review of
Pharmacological Information. Cardiovascular Drugs and Therapy (2024) 38:757–767. - Fachinformation Schweiz Erleada (Apalutamid): www.swissmedicinfo.ch
- Fachinformation Schweiz Xtandi (Enzalutamid): www.swissmedicinfo.ch
- Carles J et al. Age-related efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC): A subgroup analysis of ARASENS. Poster presentation at ASCO-GU, 2025.02.13, poster D17.
- Shore N, Tombal B, Hussain M, Saad F, Fizazi K, Alekseev B, et al. IP26-06 Long-term Safety and Tolerability of Extended Treatment with Darolutamide in Metastatic Hormone-sensitive Prostate Cancer (mHSPC): Insights fraom ARASENS Rollover Study. J Urol [Internet] 2025.05.01 [cited 2025 May 9];213(5S):e1359. Available from: https://doi.org/10.1097/01.JU.0001110200.18879.65.06
All references can be ordered at onko.ch@bayer.com
AS.: Darolutamide. I.: NUBEQA is indicated in comb. with androgen deprivation therapy (ADT) for the treatm. of adult pat. with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is indicated in comb. with docetaxel and ADT for the treatm. of adult pat. with mHSPC, for whom docetaxel therapy is indicated. NUBEQA is indicated in comb. with ADT for the treatm. of adult pat. with non-metastatic, castration-resistant prostate cancer (nmCRPC), for those who are at high risk of develop. metastases (especially with a PSA-DT ≤ 10 m.). D/A: 600 mg (two 300 mg film-coated tablets) taken 2/day with a meal (total daily dose of 1200 mg). pat. receiving NUBEQA should also receive an LHRH agonist or antagonist concurrently or have had a bilat. orchiectomy. When used in comb. with docetaxel, the 1. of 6 docetaxel cycles should begin within 6 weeks of starting NUBEQA. CI.: Hypersensitivity to the active pharmaceut. ingredient or to one of the excipients. Women who are pregnant or of childbearing potential. Spec.W./Prec.: Renal/hepatic impairment: Closely monitor pat. with severe renal impair. or moderate/severe hepatic impair. for adverse reactions. Hepatotox.: In case of liver funct. test abnormalities suggestive of idiosyncr. DILI, NUBEQA must be permanently discont. ADT can prolong the QT interval: In case of risk factors or concomitant medication that prolong the QT interval, ECG monitoring should be consid.. Contraception: Sexually active pat. must use a highly effective form of contracept.. Bone density: may be affected during treatm. with NUBEQA due to long-term testosterone suppr. Recent cardiovasc. disease: The safety of NUBEQA in pat. with a clinic. relevant cardiovasc. disease in the last 6 months has not been proven, follow current guidelines. The prescr. dose is practically “sodium free”. Do not take if you have hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. AEs.: NUBEQA: Very common: Neutrophil count decr., AST and ALT incr., bilirubin incr., fatigue. Common: Ischaemic heart disease, cardiac failure, rash, pain in extremities, fractures. NUBEQA in comb. with docetaxel: Very common: Hypertension including occasional hypertensive emergency, AST incr., ALT incr., bilirubin incr., rash. Interactions: BCRP inhibitor, OATP 1B1 and 1B3, in the case of concurrent use with corresp. substrates, follow the recommendations in the resp. prescrib. information. Weak CYP3A4 inducer. Substrate of CYP3A4, P-gp, and BCRP. Use of strong CYP3A4 inducers and P-gp inducers during treatm. with NUBEQA should be avoided. UE: Very common: Neutrophil count decreased, AST and ALT increased, Bilirubin increased, Fatigue. Common: Ischaemic heart disease, Cardiac failure, Rash, Pain in extremities, Fractures. NUBEQA in combination with Docetaxel: Very common: Hypertension including hypertensive emergency, AST increased, ALT increased, Bilirubin increased, Rash. List: B. Bayer (Schweiz) AG, 8045 Zurich. Further inform.: www.swissmedicinfo.ch.
RP-M_DAR-CH-0108-3 07/2025
PP-NUB-CH-0340-1_2025.05
