ON Nubeqa Triplet Therapy mhspc

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}

Nubeqa® in mHSPC - ARASENS study shows overall survival irrespective of patient's age¹³

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

Nubeqa® in mHSPC showed superior Overall Survival in ARASENS study⁵

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

ARASENS study design⁵

// 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.

Nubeqa® in mHSPC –ARASENS study endpoints⁵

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

Nubeqa® in mHSPC – proven efficacy in subgroups⁵ – high-volume

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

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

Get the ARASENS full publication on PubMed

Get the full ARASENS slide kit

Nubeqa® in mHSPC – proven efficacy in subgroups⁵ – high/low-risk

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

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

Patients may benefit from tolerance on placebo level⁵

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

Nubeqa® in mHSPC - ARASENS study shows overall survival irrespective of patient's age¹³

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

Nubeqa® - a low potential for Drug-Drug-Interactions^3,8,9,10-12

_{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.

DDI – Tear - off block (PDF)

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

D
DI – One pager overview (PDF)

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

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®.

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:

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-pro.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-pro.ch.
Fachinformation Schweiz Xtandi (Enzalutamid): www.swissmedicinfo-pro.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.

Identifying the right patientfor triplet therapy

Use NUBEQA®, the only ARPI with Swissmedic approval** and reimbursement# by the health insurance company in the triplet setting(3)

The results support the use of darolutamide in combination with ADT and docetaxel in all patients with mHSPC, regardless of age13