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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)

comparison triplet therapy

** 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

    ARASENS study shows overall survival irrespective of patient’s age
    ARASENS study shows overall survival irrespective of patient’s age chart 2

    The results support the use of darolutamide in combination with ADT and docetaxel in all patients with mHSPC, regardless of age
    13

    Offer to your mHSPC patients strong efficacy thanks to the combined power of Nubeqa® + docetaxel + ADT

    Nubeqa is the only ARI with confirmed efficacy in the triplet setting

    // Global, randomized, double-blind, placebo-controlled phase 3 study (NCT02799602)1,2

    ARASENS study design

    // 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

    Trust the evidence:
    Offer Nubeqa® to your high-volume patients.

    nubeqa proven efficacy high volume
    31% reduction in the risk of death
    • 77%
       patients had
      high-volume
       disease and
      23%
       had
      low-volume
       disease
    • In the smaller low-volume subgroup, the results were suggestive of a survival benefit
    Nubeqa proven efficacy low volume

    Get the ARASENS full publication on PubMed

    Get the full ARASENS slide kit

    Offer Nubeqa® to your high- and low-risk patients.

    Proven efficacy in subgroups high risk
    nubeqa proven efficacy in subgroups chart 2
    • 70%
       patients had
      high-risk
       disease and
      30%
       had
      low-risk
       disease5
    • The 30% of patients with low-risk disease in ARASENS had a similar reduction in risk of death as patients with high-risk disease and the overall population
       

    Get the ARASENS full publication on PubMed

    Get the full ARASENS slide kit

    Nubeqa patients may benefit from tolerance on placebo level

    Meta-analysis: Safety profile of darolutamide versus placebo
    7

    New data from AUA 2025: No long-term safety concerns were identified in pts who entered the ARASENS ROS.
    14

    By starting early with NUBEQA® in triplet therapy, you can help prolong overall survival and delay progression to mCRPC
    4
    without a significant increase in adverse events if NUBEQA® is added to docetaxel.
    5

    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

    Overall survival of patient with high-volume mHSPC
    Nubeqa® - a low potential for Drug-Drug-Interactions

    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.

    qr-code_ESMO

    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.

DDI – Tear - off block (PDF)

To support in patient communication with list of interactions between commonly prescribed medications and ARPIs.

DDI – Tear - off block (PDF)
German
French
Italian
Order hard copy

D
DI – One pager overview (PDF)

It gives an overview of interactions between commonly prescribed medications and ARPIs.

DDI-Overview table
German
French
Italian

Find ARPIs and drug drug interactions in prostate cancer publications here

Find more resources for patients here

Find more resources around ordering NUBEQA here

 

Hit early. Hit hard. Think NUBEQA®.

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 SCI recommends for high volume mHSPC patients a triplet 
with ADT + docetaxel + ARPI.

Download
Swiss Consensus Recommendation
on Staging and Treatement of Advanced Prostate Cancer¹

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:

  1. Templeton AJ, et al. Interdisciplinary Swiss consensus recommendations on staging and treatment of advanced prostate cancer. Swiss Med Wkly 2023;153:40108.
  2. 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.
  3. Swiss specialist information NUBEQA® , www.swissmedicinfo.ch, As of 07/24.
  4. 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.
  5. Smith MR, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med 2022;386:1132–1142.
  6. FOPH specialty list, www.spezialitaetenliste.ch, last accessed March 2025.
  7. 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.
  8. Fachinformation Schweiz Zytiga (Arbirateron): www.swissmedicinfo-pro.ch.
  9. Bolek H, et al. Androgen receptor pathway inhibitors and drug-drug interactions in prostate cancer. ESMO Open 2024;9(11):103736.
  10. 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.
  11. Fachinformation Schweiz Erleada (Apalutamid): www.swissmedicinfo-pro.ch.
  12. Fachinformation Schweiz Xtandi (Enzalutamid): www.swissmedicinfo-pro.ch.
  13. 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.
  14. 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.