New skin cancer treatment LIBTAYO (cemiplimab) available for adults with advanced cutaneous squamous cell carcinoma in Scotland

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  • the first licensed immunotherapy treatment for adults in Scotland living with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC) who are not candidates for curative surgery or curative radiation.
  • People with mCSCC have had limited treatment options until now.
  • Approximately 3,000 people are diagnosed with cutaneous squamous cell carcinoma (CSCC) every year in Scotland.

 

READING, UK – 10th February 2020 – The Scottish Medicines Consortium (SMC) has granted conditional approval of LIBTAYO® (cemiplimab) for use within NHS Scotland as monotherapy for the treatment of adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation.1 Cemiplimab is a monoclonal antibody which binds to the protein PD-1 found on T cells, helping the immune system to kill cancer cells.,     

 

“Metastatic or locally advanced cutaneous squamous cell carcinoma is very challenging to treat. It can cause disfigurement and poor quality of life, and has a poor prognosis,” said Dr Stefano Schipani, Consultant Clinical Oncologist, Beatson West of Scotland Cancer Centre, Glasgow. “I’m really pleased to see this recommendation for cemiplimab from the SMC, as it provides people in Scotland with much needed access to a new treatment option for this condition, if curative surgery or radiation is not possible.”

 

CSCC is the second most common type of skin cancer in the UK and approximately 3,000 people are diagnosed with the disease every year in Scotland.2 The disease can prove especially difficult to treat effectively when it progresses and patients can experience a significant impact on their health., Up to 5% of patients develop advanced CSCC, which is associated with significant morbidity and mortality.7,

 

“As CSCC advances, lesions can grow very large and unsightly, spread to different parts of the body and result in skin deformity and pain, leading to a significantly reduced quality of life for patients,” said Professor Charlotte Proby, Professor of Dermatology at the University of Dundee. “New treatment options for this hard-to-treat group are hugely welcomed by clinicians treating skin cancer, in order to give patients with very limited treatment options, a chance at managing symptoms.”

 

About CSCC

CSCC, also known as SCC, is a type of non-melanoma skin cancer (NMSC) that develops in the upper layers of the skin.,, CSCC can occur in any part of the body, but is more common on sun exposed sites such as the head, ears, neck and back of the hands.5 Up to 5% of patients develop advanced CSCC, which is associated with significant morbidity and mortality.7,8 Advanced CSCC includes both those with locally advanced disease (where the cancer invades deeper layers of the skin or spreads to nearby lymphonodes) and those with metastatic disease (when the cancer spreads to other distant parts of the body).6,

 

“We are very pleased by this positive recommendation from the SMC for cemiplimab, which will expand the treatment options for patients in Scotland living with this hard to treat form of advanced skin cancer,” said Dr Marc Moodley, Medical Director, Sanofi Genzyme.Sanofi has a long legacy of developing innovative medicines for oncology patients but the biggest reward is when our medicines are able to reach those patients who can benefit the most.”

 

The EMPOWER-CSCC-1 trial

The SMC recommendation is based on data from the pivotal, open-label, multi-centre, non-randomised Phase 2 [EMPOWER-CSCC-1] trial (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-centre, open-label, non-randomised Phase 1 trial.

 

About LIBTAYO® (cemiplimab)

Cemiplimab is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1).3,4 The European Commission granted conditional marketing authorisation for cemiplimab for the treatment of adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation on 1 July 2019.

 

LIBTAYO® (cemiplimab) is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

 

 

About Sanofi

 

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

 

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

 

Sanofi, Empowering Life.

 

 

Media Relations Contact

Claire Whitmarsh

Sanofi UK & Ireland

Tel.: 01183 543 485 or 07935 503 416

claire.whitmarsh@sanofi.com

 

 

Nick Murphy

Syneos Health

Tel.: 020 7632 1929

nicholas.murphy@syneoshealth.com

 

References

 

Scottish Medicines Consortium Medicines Advice for cemiplimab (LIBTAYO) Available at: https://www.scottishmedicines.org.uk/medicines-advice/cemiplimab-libtayo-full-smc2216/ Accessed 10 February 2020

Scottish Referral Guidelines for Suspected Cancer. Available at: http://www.cancerreferral.scot.nhs.uk/skin-cancers/?alttemplate=Guideline Accessed: January 2020.

Burova E, Hermann A, Waite J, et al. Characterization of the Anti-PD-1 Antibody REGN2810 and Its Antitumor Activity in Human PD-1 Knock-In Mice. Molecular cancer therapeutics. 2017;16(5):861‒870. Available at:

http://mct.aacrjournals.org/content/molcanther/16/5/861.full.pdf Accessed: January 2020.

National Cancer Institute. NCI Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/795107 Accessed: January 2020.

Stratigos, Alexander et al. Diagnosis and treatment of invasive squamous cell carcinoma of the skin: European consensus-based interdisciplinary guideline. European Journal of Cancer. 1989-2007; Vol 51(14);14.

Soura E, Gagari E, Stratigos A. Advanced cutaneous squamous cell carcinoma: how is it defined and what new therapeutic approaches are available? Curr Opin Oncol. 2019; 31(5):461-468.

How Patients With Advanced/Metastatic CSCC Present. Targeted oncology. Available at: https://www.targetedonc.com/precision-medicine/advanced-cscc/how-patients-with-advanced-metastatic-cscc-present Accessed: January 2020. 

British Skin Foundation. Squamous Cell Carcinoma. Available at: https://www.britishskinfoundation.org.uk/scc Accessed January 2020.

NHS. Skin cancer (non-melanoma). Available at: https://www.nhs.uk/conditions/non-melanoma-skin-cancer/ Accessed: January 2020.

Cancer.org. What Is Melanoma Skin Cancer? Available at: https://www.cancer.org/cancer/melanoma-skin-cancer/about/what-is-melanoma.html Accessed: January 2020.

Skin Cancer Foundation. Treatment Option. Available at: https://www.skincancer.org/skin-cancer-information/squamous-cell-carcinoma/scc-treatment-options  Accessed: January 2020.

Migden M, Rischin D, Schmults C, et al.  PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Eng J Med. 2018; 379:341-351.

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