Bayer is pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended Stivarga® (regorafenib) as a treatment option for adult patients with metastatic colorectal cancer who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy) or when these treatments are unsuitable.1
Dr Naureen Starling, Consultant Medical Oncologist, Royal Marsden NHS Foundation Trust (London & Sutton, Surrey) supports the NICE recommendation: “I’m pleased that patients with advanced bowel cancer being treated in the NHS will have another treatment option. I think patients will welcome the opportunity to have a targeted oral therapy.”
Regorafenib is administered orally (by mouth), meaning people may be able to take the medicine at home rather than in a hospital. The NICE committee agreed that people with mCRC who have had previous treatments have an unmet clinical need and would welcome new treatment options.1
Colorectal cancer is a malignant tumour arising from the lining of the large intestine (colon and rectum). 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. This type of cancer - classified as stage 4 or advanced, secondary or metastatic disease - is the fourth most common in the UK, with over 42,000 new cases diagnosed each year.2 Survival rates have improved, with a five-year survival rate of almost 60%3 with access to surgery and drugs helping to extend life.
Metastatic colorectal cancer can have a significant impact on quality of life, especially for those diagnosed at later stages, when survival rates are poor. There are limited effective treatment options available, so treatments which give small improvements in quality of life and extensions to length of life are important.1
Dr Janet Graham, Consultant Medical Oncologist, commented on the recommendation: “We are seeing a growing number of patients who are fit and keen to have further treatment in the third- and fourth-line setting. We are pleased to have regorafenib as a further option - it is important that all patients can have access to all the potential drugs that might target their cancer”.
Janine De Beer, Oncology Medical Director, Bayer UK, said “Regorafenib, the only licensed Tyrosine Kinase Inhibitor for mCRC, is now available for use by the NHS in England. The recommendation by NICE 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 the NHS as a whole.”
The NICE recommendation is based on two randomised, double-blind, phase III clinical trials - CORRECT and CONCUR4,5. These compared regorafenib with placebo in adults with metastatic colorectal cancer whose cancer had progressed within three months on approved standard treatment. Standard treatment included: fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, cetuximab, and panitumumab. In CORRECT, the median overall survival was 6.4 months for people having regorafenib and 5 months for people having placebo (hazard ratio 0.77, 95% confidence interval 0.64 to 0.94)4. For CONCUR, 8.8 months was the median overall survival for people in the regorafenib arm. In the placebo arm this was 6.3 months (hazard ratio 0.55, 95% confidence interval 0.40 to 0.77)5. The pooled datasets from both studies delivered an overall survival hazard ratio of 0.68 (95% confidence interval 0.59 to 0.79).1
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Notes to Editors:
A full Summary of Product Characteristics for regorafenib can be found at: https://www.medicines.org.uk/emc/product/1263
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.6
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.
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 ageing 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.
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1. NICE - https://www.nice.org.uk/guidance/gid-ta10924/documents/final-appraisal-determination-document : published 8th February, 2023
2. Cancer Research UK: Bowel cancer statistics | Cancer Research UK – last accessed on 3rd February 2023
3. Cancer Research UK: Bowel cancer survival statistics | Cancer Research UK – last accessed on 3rd February 2023
4. 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.
5. 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.
6. Stivarga® (regorafenib) 40mg film coated tablets Summary of Product Characteristics – link accessed on 8th February 2023: https://www.medicines.org.uk/emc/product/1263
RP-M_REG-GB-0003 Date of Preparation: February 2023