NICE recommends Bayer’s NUBEQA®▼ (darolutamide) + ADT in combination with docetaxel

for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)

• More prostate cancer patients in England and Wales will now have access to NUBEQA, following the few hundred patients^[i] who have already received the medication through the early access agreement between Bayer and NHS England^[ii]
• The decision from NICE follows the accelerated regulatory approval by MHRA under Project Orbis* in November 2022.^[iii] Darolutamide + androgen deprivation therapy (ADT) in combination with docetaxel was the first triple combination treatment made available by the NHS in England for patients with mHSPC³ 
• Darolutamide + ADT in combination with docetaxel demonstrated a statistically significant reduction in risk of death in patients with mHSPC, as well as several improvements in secondary endpoints^[iv],[v]

Bayer today announces that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending darolutamide + ADT in combination with docetaxel as a treatment option for patients with mHSPC.^[vi]

Following darolutamide’s approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for mHSPC patients in November 2022,³ Bayer announced a commercial agreement with the NHS in England to ensure clinicians could arrange early access.² Since November 2022, a few hundred eligible patients with mHSPC have received the medication in England.¹ Today’s decision by NICE allows additional eligible patients with mHSPC in England and Wales to receive this medication.

Dr Simon Hughes, Consultant Clinical Oncologist, Guy’s and St Thomas’s NHS Foundation Trust, said: “When prostate cancer has spread to other parts of the body we have limited treatment options that are both effective and well tolerated. We welcome today’s NICE recommendation that extends the availability of darolutamide, in England and Wales, to patients with metastatic hormone-sensitive prostate cancer, in addition to the existing indication for patients with non-metastatic hormone-resistant prostate cancer. Oncologists now have an additional treatment option to offer to their patients.”

The decision by NICE is based on the results from 1,305 patients who participated in the ARASENS clinical trial.^4,5 This randomised, Phase III, multi-centre, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety profile of oral darolutamide + ADT in combination with docetaxel in patients with mHSPC. Results showed that the combination treatment led to a statistically significant 32.5% reduced risk of death, with secondary endpoints being time to castration-resistant prostate cancer (CRPC), time to pain progression and time to first symptomatic skeletal event, measured at 12-week intervals.^4,5 Overall incidence of adverse events (AEs) was similar between treatment arms, despite longer treatment exposure for those treated with darolutamide (median 41.0 versus 16.7 months).^4,5

Chiara De Biase, Director of Support & Influencing at Prostate Cancer UK, said: “We are extremely pleased that men can now start to benefit from this brand-new combination treatment, giving hundreds of men each year another option which has been shown to help them live longer. This is the first triple therapy of its kind to be made available on the NHS for prostate cancer, blazing a trail for more new combination treatments that have the potential to be even more effective in the future. The next step in our work will be to help establish which men most benefit from this approach, so that every man receives precise therapies tailored to his disease.”

“The positive recommendation by NICE paves the way for additional eligible patients in England and Wales to benefit from this innovative medication, following the early access we agreed with NHS England approximately 6 months ago,” said Antonio Payano, CEO Bayer UK & Ireland, adding: “We remain committed to investigating the potential of darolutamide in prostate cancer with additional clinical trials and working with the relevant UK authorities to help make it available to as many eligible patients as possible.”

Darolutamide was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. It is currently approved for the treatment of patients with mHSPC in combination and docetaxel and patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.³ It is also being investigated in further studies across various stages of prostate cancer. 

* Project Orbis is an initiative of the FDA Oncology Center of Excellence, providing a framework for concurrent submission and review of oncology products among international partners

Bayer Media Contact:  

Hayley Wood

E-mail: hayley.wood@bayer.com

Mobile: +44 (0)7425 611965 

Notes to Editors 

About metastatic hormone-sensitive prostate cancer (mHSPC) 

There are over 52,000 cases of prostate cancer in the UK each year,^[i] with over 15,000 new cases of metastatic prostate cancer confirmed each year.^[ii]

Metastatic hormone-sensitive prostate cancer (mHSPC) is cancer that has spread beyond the prostate to other parts of the body and still responds to treatment with hormone therapy.^[iii] mHSPC precedes the development of metastatic castration-resistant prostate cancer (mCRPC),^[iv] which no longer responds to treatment with hormone therapy.

Despite treatment, most men with mHSPC will eventually progress to mCRPC,^[v] a condition with limited survival. 

About NUBEQA^®▼ (darolutamide)

Darolutamide is an ARi (androgen receptor inhibitor) that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.³ 

Darolutamide was authorised in March 2020 in the European Union under the brand name NUBEQA^®▼ for the treatment of men with non-metastatic castration resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.¹² It was authorised in November 2022 in the UK for the treatment of patients with mHSPC in combination with docetaxel.³ 

The Summary of Product Characteristics (SmPC) for darolutamide can be found at: https://www.medicines.org.uk/emc/product/11324 

About the ARASENS Trial 

The ARASENS trial is a randomised, Phase III, multi-centre, double-blind, placebo-controlled trial which was prospectively designed to investigate the efficacy and safety profile of oral darolutamide, an ARi, plus ADT and the chemotherapy docetaxel in patients with mHSPC.^3,5 A total of 1,306 newly diagnosed patients were randomised in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel. 

The primary endpoint of this trial was overall survival (OS).⁵ Secondary endpoints included time to CRPC, time to pain progression, time to first SSE, all measured at 12‐week intervals, as well as AEs as a measure of safety profile and tolerability. Overall incidence of adverse events (AEs) was similar between treatment arms, despite longer treatment exposure for those treated with darolutamide (median 41.0 versus 16.7 months).^4,5

About Oncology at Bayer  

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes six marketed products across various indications and several compounds in different stages of clinical development. Bayer focuses its research activities on first-in-class innovations across the following scientific platforms: Oncogenic Signalling, Targeted Alpha Therapies, and Immuno-Oncology. Across the areas of focus, we have several prostate cancer treatments on the market or in development, with the goal of extending survival while limiting side effects of treatment throughout the different stages of the disease. Another key focus at Bayer is on innovative precision oncology treatments, with an approved TRK inhibitor exclusively designed to treat tumours that have an NTRK gene fusion, the oncogenic driver of tumour growth and spread, and another TRK inhibitor advancing through the pipeline. The company’s approach to research prioritises targets and pathways with the potential to impact the way that cancer is treated. 

About Bayer 

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.co.uk.

Forward-Looking Statements  

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References 

^[1] Bayer, plc. 2023. Final number of mHSPC patients treated with darolutamide through the early access agreement between Bayer and NHS England.

^[1] NHS England. NHS fast-track life-extending prostate cancer drug to patients. Available at: https://www.england.nhs.uk/2022/11/nhs-fast-tracks-life-extending-prostate-cancer-drug/ Last accessed: May 2023

^[1] NUBEQA^® (darolutamide) 300 mg film-coated tables Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11324 Last accessed: May 2023.

^[1] Smith, RA, et al. Overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer in the phase 3 ARASENS trial. Oral Abstract session at the ASCO GU Cancers Symposium, 17-19 February 2022, San Francisco, California, USA. Available at: https://meetings.asco.org/abstracts-presentations/205326 Last accessed: May 2023.

^[1] Smith, RA, et al. Darolutamide and survival in metastatic hormone-sensitive prostate cancer. NEJM 2022 Feb 17, doi:10.1056/NEJMoa2119115.

^[1] Final draft guidance. National Institute for Health and Care Excellence. Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer. Available from: https://www.nice.org.uk/guidance/gid-ta10860/documents/final-appraisal-determination-document Last accessed: May 2023.

^[1] Cancer Research UK. Prostate cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer Last accessed: May 2023.

^[1] Prostate Cancer UK. Advanced prostate cancer: your questions answered about the disease affecting Bill Turnbull. Available at: https://prostatecanceruk.org/about-us/news-and-views/2018/10/advanced-disease-blog Last accessed: May 2023.

^[1] Cancer.Net. ASCO answers: Prostate Cancer. Available at: https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf Last accessed: May 2023.

^[1] Cattrini, et al. Current Treatment Options for Metastatic Hormone-Sensitive Prostate Cancer. Cancers.2019 11(9), p.1355.

^[1] Ritch, C. and Cookson, M. Recent trends in the management of advanced prostate cancer. F1000Res. 2018 Sep 21;7:F1000 Faculty Rev-1513.

¹² Nubeqa (darolutamide). European Medicines Agency. Available from:  https://www.ema.europa.eu/en/medicines/human/EPAR/nubeqa#authorisation-details-section Last accessed: May 2023 

RP-NUB-GB-0424     Date of Preparation: May 2023