Advanced kidney cancer patients in Scotland become amongst the first in world to access CABOMETYX®▼ (cabozantinib) in combination with OPDIVO® (nivolumab) via NHS Scotland, following SMC acceptance*

Advanced kidney cancer patients in Scotland become amongst the first in world to access CABOMETYX^®▼ (cabozantinib) in combination with OPDIVO^® (nivolumab) via NHS Scotland, following SMC acceptance*

• *The Scottish Medicines Consortium has accepted use of cabozantinib in combination with nivolumab as a first-line treatment for people with advanced renal cell carcinoma (RCC),[i] becoming one of the first in the world to do so through a Health Technology Assessment (HTA).[ii]
• Over 1,000 people are diagnosed with renal cell carcinoma (kidney cancer) each year in Scotland.[iii]

SLOUGH, UK, 11 OCTOBER 2021 – Ipsen, UK, today welcomed the decision from the Scottish Medicines Consortium (SMC) to recommend cabozantinib for use by the NHS across Scotland, in combination with nivolumab for the first-line treatment of advanced RCC in adults.ⁱ From today, up to approximately 230 eligible Scottish patients could benefit annually from the treatment combination.[iv]

“Today’s news is a clear demonstration of Scotland being at the forefront of cancer care, with local patients the first to benefit from this treatment approach. With incidence of RCC rising in Scotland over the last decade, this recommendation will mark an important milestone for patients with advanced disease.

The combination of cabozantinib and nivolumab combines agents which both block the growth of blood vessels in cancer tumours and those which harness the body’s immune system to help find and fight cancer.” said Robert Jones, Professor of Clinical Cancer Research, University of Glasgow.  

The decision to recommend cabozantinib in combination with nivolumab by the SMC is supported by data published in the New England Journal of Medicine.[v] In a landmark phase III study, the risk of death was decreased by 34% with cabozantinib in combination with nivolumab, compared to a currently available therapy, sunitinib. Additionally, the study met its primary endpoint of progression free survival (PFS), with median progression free survival doubling from 8.3 months on a currently available therapy, sunitinib, to 17.0 months when compared to cabozantinib in combination with nivolumab (HR (95% CI), 0.52 (0.43-0.64) P < 0.0001).[vi]

The adverse event profile with cabozantinib and nivolumab remained consistent with previous reports for each agent as monotherapy, and no new safety signals were identified among all treated patients.^vi

Dr Manjinder Bains, Medical Director at Ipsen UK and Ireland comments: “Through the pragmatic and innovative approach taken by the Scottish Government and NHS Scotland during COVID, we are delighted that Scotland has become the first country in the world to have completed a health technology assessment for the use of cabozantinib in combination with nivolumab in this indication. Ipsen has been working in the field of oncology for over 35 years and we are delighted that this decision from the SMC appraisal during this time will provide comfort and hope to many people affected by advanced RCC in Scotland.”

ENDS

Contacts:

NOTES TO EDITORS

About Cabometyx (Cabozantinib)

The detailed recommendations for the use of Cabometyx^® are described in the Summary of Product Characteristics (SmPC) from both the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency

Cabometyx is marketed by Exelixis, Inc. in the United States and by Takeda Pharmaceutical Company Limited in Japan. Ipsen has exclusive rights for the commercialisation of Cabometyx outside of the U.S. and Japan. Cabometyx is a registered trademark of Exelixis, Inc.

About Kidney Cancer (advanced renal cell carcinoma) in Scotland

Data published by Public Health Scotland in May 2021 shows that in Scotland, cases of RCC have continued to increase over the last decade, particularly in men, where incidence rose over 20%, which was more than most other cancer types.^[vii] RCC is often diagnosed at a late stage, where is referred to as advanced RCC.^[viii]

5-year survival rates for Scotland are on average 15% lower compared to the European average and the lowest among the devolved nations of the UK.^viii Survival rates, however, are improving, thanks to the ongoing efforts and research being conducted in both the quality and breadth of treatments available.ⁱⁱⁱ

About Ipsen

Our team in the UK is a core part of Ipsen’s global biopharmaceutical business and is driven by the belief that patients don’t have time to wait. We have a biotech mindset coupled with pharmaceutical capabilities and have invested in a robust business presence in the UK that spans the early stages of R&D (Abingdon, Oxford) through to in-house manufacturing (Wrexham, Wales) so we can effectively deliver on our promise to UK patients. As part of this investment in the heart of UK life sciences, we employ over 700 people across our three major UK sites, including our commercial headquarters in Bath Road, Slough.

Opdivo^® is a registered trademark of Bristol-Myers Squibb Company.

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References

[i] Scottish Medicines Consortium. Cabozantinib (Cabometyx). Available at: https://www.scottishmedicines.org.uk/medicines-advice/cabozantinib-cabometyx-abb-smc2386/ Last accessed: October 2021

[ii] Ipsen Data on File: [CMX-UK-003563]

[iii] Public Health Scotland. Cancer Statistics, Kidney Cancer. Available at: https://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Kidney/ Last accessed: October 2021

[iv] Ipsen Data on File: [CMX-UK-003564]

[v] New England Journal of Medicine (NEJM). Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2026982 Last accessed: September 2021

[vi] Motzer R.J., et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal cell carcinoma: outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. Presented at the Genitourinary Cancers Symposium 2021

[vii] Public Health Scotland. Cancer Incidence in Scotland. Available at: https://publichealthscotland.scot/publications/cancer-incidence-in-scotland/cancer-incidence-in-scotland-cancer-incidence-and-prevalence-in-scotland-to-december-2019/ Last accessed: September 2021

[viii] Kidney Cancer UK. 2020 Patient Survey. Available at: https://www.kcuk.org.uk/booklets/KCUK-patient-survey-2020/#page=2 Last accessed: September 2021

Job Code: CMX-UK-003529

Date of Preparation: October 2021