For UK Medical, Trade and Pharma Media

Scottish Medicines Consortium (SMC) recommends two Bayer cancer treatments for use within NHSScotland:

 • NUBEQA®▼ (darolutamide) + ADT in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)1• STIVARGA® (regorafenib) as monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy4
 • Prostate cancer patients in Scotland will now have access to NUBEQA ®▼ (darolutamide), following the accelerated regulatory approval by MHRA under Project Orbis*2• Patients in Scotland with metastatic colorectal cancer can now receive treatment with STIVARGA® (regorafenib), having shown statistically significant benefits in overall survival compared to placebo in two Phase III studies5,6
 • Darolutamide + androgen deprivation therapy (ADT) in combination with docetaxel was the first triple combination treatment made available by the NHS in England from November 2022 for patients with mHSPC2,3 

 

Bayer today announces that the Scottish Medicines Consortium (SMC) has published advice on two Bayer cancer drugs, recommending both for use in NHSScotland: NUBEQA® (darolutamide) + ADT in combination with docetaxel as a treatment option for patients with metastatic hormone-sensitive prostate cancer (mHSPC)1 and STIVARGA® (regorafenib) as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies (these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy)4.

 

Darolutamide plus androgen deprivation therapy (ADT) + docetaxel in mHSPC

Today’s Advice from the SMC allows eligible patients with mHSPC in Scotland to receive this medication in combination with ADT and docetaxel. It follows the publication of the NICE guidance on darolutamide + ADT in combination with docetaxel for mHSPC patients in England and Wales in June 2023.7 Darolutamide received the accelerated regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for mHSPC patients in November 2022.2 Subsequently, Bayer announced an early access commercial agreement between Bayer and NHS England3, which allowed early access for a few hundred eligible patients with mHSPC to receive the medication in England8 ahead of the publication of the NICE guidance, making darolutamide + ADT in combination with docetaxel the first triple combination treatment made available by the NHS in England for patients with mHSPC2,3.

 

In Scotland, prostate cancer is the most common cancer in males with around 3,394 new cases diagnosed in 20209, it is estimated that almost a third (29%) of these were diagnosed at a late stage when the disease had metastasised.9

 

Professor Rob Jones, University of Glasgow, said: “Probably the most important discovery in the treatment of advanced prostate cancer in recent years is that patients gain most benefit from anti-cancer medicines if they receive them early after the diagnosis. This decision means that Scottish patients can now benefit from a wider choice of early treatment options after diagnosis with advanced prostate cancer. I’d also like to pay tribute to the patients in Scotland and elsewhere who took part in the clinical trial which demonstrated the benefits of this treatment.”

 

The Advice given by the SMC followed a submission assessed under the orphan medicine process and is based on the results from 1,305 patients who participated in the ARASENS clinical trial.10 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 (HR=0.68, HR 95% CI[0.57; 0.80; p<0.0001]).10,11 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).10,11

 

Chiara De Biase, Director of Support & Influencing at Prostate Cancer UK, said: “I’m extremely pleased that men in Scotland can now benefit from this first-of-its-kind combination treatment which we know can give a man with advanced prostate cancer a longer life. This innovative triple therapy will not only help the men who need it now, but also paves the way to future combination treatments that have the potential to be even more effective.  

 

“We'll continue to engage with healthcare professionals and researchers to help establish which men most benefit from this approach, so that every man gets the most effective treatment tailored to his disease. We face huge regional health inequalities in the UK. For example, 1 in 3 men diagnosed in Scotland have advanced prostate cancer at diagnosis, compared to 1 in 8 men in London. Today’s decision will contribute to closing that unfair gap, as men across the whole of the UK can finally benefit from this advancement in treatment options.”

 

“The Advice by the SMC now opens the doors to patients in Scotland who may be eligible to benefit from this innovative treatment, following the early access we agreed with NHS England at the end of 2022,” said Antonio Payano, CEO Bayer UK & Ireland, adding: “We are resolutely committed to investigating the potential of darolutamide in prostate cancer 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 with ADT and docetaxel and for patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.2 It is also being investigated in further studies across various stages of prostate cancer.

Reporting of side effects:

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting and side effects. See www.mhra.goc.uk/yellowcard for how to report side effects, or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should aso be reported to Bayer plc. Tel.: 0118 206 3500, Fax: 0118 206 3703, Email: pvuk@bayer.com 

Regorafenib in mCRC 

Colorectal cancer is a malignant tumour arising from the lining of the large intestine (colon and rectum).12 Metastatic colorectal cancer (mCRC) refers to cancer that has spread beyond the large intestine and nearby lymph nodes to other parts of the body, such as the lungs and liver.13 This type of cancer - classified as stage 4 or advanced, secondary or metastatic disease - is the third most common cancer in Scotland, accounting for 12% of cancer diagnoses per year; in 2017, there were 3,800 new cases. CRC is ranked second for mortality in Scotland, with 11% of all cancer-related deaths being due to CRC.14

Janine De Beer, Oncology Medical Director, Bayer UK, said “Regorafenib, the only licensed Tyrosine Kinase Inhibitor for mCRC, is now available for use by NHSScotland. The SMC Advice means that patients’ lives could be extended, and their ongoing treatment can be managed outside of the hospital – this is of significance not only to the patient, families, and carers but also to NHSScotland as a whole.”

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,15 with over 15,000 new cases of metastatic prostate cancer confirmed each year.16

 

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.17 mHSPC precedes the development of metastatic castration-resistant prostate cancer (mCRPC),18 which no longer responds to treatment with hormone therapy.  Despite treatment, most men with mHSPC will eventually progress to mCRPC,19 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.

 

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.20 It was authorised in November 2022 in the UK for the treatment of patients with mHSPC in combination with docetaxel.2 

 

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.2,11 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).11 Secondary endpoints included 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).10,11 

 

About Regorafenib (STIVARGA®)

Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R). 

 

In the UK, regorafenib is indicated as monotherapy for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic gastro-intestinal stromal tumour (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib, and for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.21

 

A full Summary of Product Characteristics for regorafenib can be found at:  https://www.medicines.org.uk/emc/product/1263 

 

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.

 

 

 

RP-M_DAR-GB-0075     Date of Preparation: October 2023 

References

* 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.

 

[1] Healthcare Improvement Scotland: SMC Advice on new medicines; SMC2604 darolutamide 300mg film-coated tablets (Nubeqa®) Bayer Plc. Access online 9th October 2023: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-ft-resub-smc2604/ 

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

[3] 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: October 2023

[4] Healthcare Improvement Scotland: SMC Advice on new medicines; SMC2562 regorafenib film-coated tablets (Stivarga®) Bayer Plc. Accessed online 9th October 2023: https://www.scottishmedicines.org.uk/medicines-advice/regorafenib-stivarga-full-smc2562/ 

[5] A. Grothey et al - Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial: Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

[6] J. Li et al - Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial: Lancet Oncol. 2015 Jun;16(6):619-29. doi: 10.1016/S1470-2045(15)70156-7. Epub 2015 May 13. 

[7] NICE Guidance. Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer. https://www.nice.org.uk/guidance/ta903/resources/darolutamide-with-androgen-deprivation-therapy-and-docetaxel-for-treating-hormonesensitive-metastatic-prostate-cancer-pdf-82615424991685 

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

 

[9] Public Health Scotland. Cancer Incidence in Scotland - To December 2020. Published 12 April 2022. Available from: https://www.publichealthscotland.scot/media/12645/2022-04-12-cancer-incidence-report.pdf Last accessed: October 2023

[10] 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: October 2023.

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

[12] Cancer Research UK. Bowel Cancer. Last accessed: October 2023.

[13] Cancer Research UK. Stage 4 bowel cancer. Last accessed: October 2023.

[14] Public Health Scotland (PHS). Cancer Statistics – Colorectal Cancer. https://www.isdscotland.org/health-topics/cancer/cancer-statistics/colorectal/#summary Last accessed: October 2023.

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

[16] 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: October 2023.

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

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

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

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

[21] Stivarga® (regorafenib) 40mg film coated tablets Summary of Product Characteristics – link accessed on 4th October 2023:  https://www.medicines.org.uk/emc/product/1263