NUBEQA®▼ (darolutamide) + ADT in combination with docetaxel licenced by MHRA and made immediately available through NHS England early access deal for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)

NUBEQA^®▼ (darolutamide) + ADT in combination with docetaxel licenced by MHRA and made immediately available through NHS England early access deal for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)

 

• NUBEQA^® (Darolutamide) + Androgen Deprivation Therapy (ADT) in combination with docetaxel is the first prostate cancer treatment to be made available by the NHS in England through an early national access agreement, following accelerated regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis*^[i]
• Bayer has entered a commercial agreement with NHS England - the first healthcare system in Europe to fast-track the medicine - which ensures clinicians can arrange early access for their eligible patients in England while NICE completes its assessment^[ii]
• The approval comes after the presentation of the ARASENS Phase III clinical trials data at the 2022 ASCO GU Cancers Symposium in February 2022 and their simultaneous publication in The New England Journal of Medicine^[iii],[iv]

 

Reading, UK, 28^th November 2022 - Bayer today announces that darolutamide + ADT in combination with docetaxel, for the treatment of patients with metastatic hormone sensitive prostate cancer (mHSPC), is available immediately in England for eligible patients, following marketing authorisation from the MHRA and through a first-in-Europe early access agreement with NHS England.² This follows the initial licence for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in 2020.^[v]

 

Darolutamide for mHSPC has been reviewed and approved by the MHRA through Project Orbis* which aims to accelerate review and approval of promising cancer therapies.¹ The commercial agreement between NHS England and Bayer is the first for a prostate cancer therapy and enables early access for eligible NHS patients in England for this indication while the National Institute for Health and Care Excellence (NICE) completes its ongoing appraisal. 

 

“The ARASENS trial has shown us that darolutamide + ADT in combination with docetaxel significantly increased overall survival in men with metastatic hormone sensitive prostate cancer” said Dr Ursula McGovern, FRCP PhD Consultant Medical Oncologist, University College London Hospitals NHS Foundations Trust and UK Chief Investigator in the study.  “Intensification of treatment was generally well tolerated, and this novel combination of treatments should be considered for appropriate patients with mHSPC.”            

 

Today’s approval is founded on results from 1,305 patients who participated in the ARASENS clinical trial.^3,4 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. Below 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.^3,4

 

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). ^3,4

 

“We are delighted that men with prostate cancer in England will have early access to another innovative treatment option,” said Antonio Payano, CEO Bayer UK & Ireland, adding: “It’s vital that NHS patients are able to benefit from the best standard of care and full range of emerging therapies today and in the future. It requires direct and sustained collaboration between government, the NHS and the life sciences sector to properly realise these shared ambitions.”

 

Darolutamide was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE),^[vi]as well as a Phase III trial evaluating darolutamide as an adjuvant treatment for localised prostate cancer with very high risk of recurrence (DASL-HiCaP).^[vii]

 

-ENDS-

 

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,^[viii] with over 15,000 new cases of metastatic prostate cancer confirmed each year.^[ix]

 

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.^[x] mHSPC precedes the development of metastatic castration-resistant prostate cancer (mCRPC),^[xi] which no longer responds to treatment with hormone therapy.

 

Despite treatment, most men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC)^[xii] a condition with limited survival.

 

About NUBEQA^®▼ (darolutamide)

Darolutamide is an ARi 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.⁵

 

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. 

 

The Summary of Product Characteristics (SmPC) for darolutamide for nmCRPC can be found at: https://www.medicines.org.uk/emc/product/11324 The new SmPC for mHSPC will be available imminently and is attached to this press release.⁵

 

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.^4,5 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).⁴ Secondary endpoints included time to CRPC, time to pain progression, time to first SSE, time to initiation of subsequent anticancer therapy, all measured at 12‐week intervals, as well as AEs as a measure of safety profile and tolerability.

 

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 planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com. 

 

 

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.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

 

 

References 

 

 

 

^[i] Project Orbis, https://www.gov.uk/guidance/guidance-on-project-orbis#contents, Last accessed: November 2022 

^[ii] NHS England – News: https://www.england.nhs.uk/news/  

^[iii] 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: November 2022.

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

^[v] NUBEQA^® (darolutamide) 300 mg film-coated tables Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11324 Last accessed: November 2022.

^[vi] ClinicalTrials.Gov. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). Available at: https://clinicaltrials.gov/ct2/show/NCT04736199 Last accessed: November 2022.

^[vii] ClinicalTrials.Gov. Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (DASL-HiCaP). Available at: https://clinicaltrials.gov/ct2/show/NCT04136353 Last accessed: November 2022.

^[viii] Cancer Research UK. Prostate cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer? Last accessed: November 2022.

^[ix] 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: November 2022

^[x] Cancer.Net. ASCO answers: Prostate Cancer. Available at: https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf Last accessed: February 2022.

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

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