NEW LICENSE NOW AVAILABLE
Bayer receives Medicines and Healthcare Products Regulatory Agency (MHRA) authorisation for a new indication of NUBEQA® (darolutamide) + androgen deprivation therapy (ADT) as a doublet treatment option for men with metastatic hormone-sensitive prostate cancer (mHSPC).
Efficacy that doesn't compromise your patient's QoL. Choose NUBEQA in mHSPC.
- The marketing authorisation is based on results from the pivotal Phase III ARANOTE trial evaluating the efficacy and safety of NUBEQA, an oral androgen receptor inhibitor, + androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC)
- In the UK, prostate cancer is the most common cancer amongst men, with over 55,000 men being diagnosed each year and more than 15,000 new cases confirmed as metastatic prostate cancer.
- NUBEQA + ADT is now authorised in the UK for use as a treatment option in mHSPC, with and without docetaxel, based on two pivotal Phase III studies in mHSPC
The ARANOTE trial is a randomised, double-blind, placebo-controlled Phase III study, designed to assess the efficacy and safety of NUBEQA + androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 669 patients were randomised 2:1 to receive either 600mg of NUBEQA twice daily or placebo in addition to ADT.
The primary endpoint of this study was radiological progression-free survival (rPFS), measured as time from randomisation to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints included overall survival (time to death from any cause), time to initiation of subsequent anti-cancer therapy, time to CRPC (castration-resistant prostate cancer) event, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.
The trial showed that NUBEQA + ADT significantly improved radiological progression-free survival (rPFS), reducing the risk of radiological progression or death by 46% (HR 0.54; 95% CI 0.41–0.71; P<0.0001), compared to placebo + ADT. The rPFS rates at 24 months were 70.3% in the NUBEQA group and 52.1% in the placebo group. Consistent benefits in rPFS were observed across prespecified subgroups, including in patients with high-volume (HR 0.60; 95% CI 0.44-0.80) and low-volume (HR 0.30; 95% CI 0.15-0.60) mHSPC.
The incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups. Treatment discontinuations due to TEAEs were lower in patients receiving NUBEQA + ADT compared to placebo + ADT (6.1% vs 9.0%). NUBEQA is the only ARI to demonstrate fewer discontinuation rates when added to ADT vs ADT + placebo in Phase III clinical trial.
"Despite significant advances in prostate cancer care, there is still a need for widening the options for men with advanced prostate cancer that can maintain quality of life as much as possible alongside improving their outcomes from prostate cancer, meaning more quality time overall. This means we have to adapt treatment to the individual person, taking into account other medical problems, such as medication, age and what their treatment goals and preferences are. Today’s authorisation of darolutamide plus ADT for use in metastatic hormone-sensitive prostate cancer provides me and other UK physicians with greater flexibility to tailor treatment to an individual patient's needs.”
- Professor Alison Birtle, Consultant Clinical Oncologist at the Rosemere Cancer Centre, Lancashire Teaching Hospitals, Honorary Clinical Professor in the Faculty of Biology, Medicine & Health at the University of Manchester and Honorary Clinical Professor at The University of Central Lancashire.
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Prescribing information for NUBEQA® (darolutamide) can be found here.
PP-NUB-GB-2446 | June 2025