NICE recommends LIBTAYO®▼(cemiplimab) for routine NHS commissioning as the first and only systemic treatment for advanced CSCC in England

NICE recommends LIBTAYO^®▼(cemiplimab) for routine NHS commissioning as the first and only systemic treatment for advanced CSCC in England  

Reading, UK - 25th May 2022 - The National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Determination recommending LIBTAYO^® (cemiplimab) as the first and only systemic treatment option in England for metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults when curative surgery or curative radiation is not appropriate.[1] This means eligible patients will have full NHS access in England via routine commissioning. Approximately 28,000 people are diagnosed with CSCC every year, of which around 2% will be at risk of developing metastatic disease.[2]^,[3]

The decision comes in the third year after NICE initially recommended cemiplimab in 2019 to be made available through the Cancer Drugs Fund (CDF), an interim programme designed to increase the speed at which treatments are brought to patients within spending margins.¹ Since then, NICE has collected additional real-world data to assess the clinical and cost effectiveness of cemiplimab further, culminating in the granting of routine funding in the NHS.

Dr Andrew Sykes

Consultant Clinical Oncologist, The Christie NHS Foundation Trust, Manchester

“I am delighted to hear of NICE’s decision to recommend cemplimab via NHS routine commissioning. Locally advanced and metastatic cutaneous squamous cell carcinoma remains particularly challenging to treat, and there are limited options for patients when surgery or radiotherapy haven’t been successful, resulting in a poor prognosis. NICE’s recommendation in this setting is really important, and provides clarity for healthcare professionals and certainty of this treatment continuing to be available in the future. Having routine NHS access to cemiplimab is vital as we attempt to improve outcomes, and is welcome news for hundreds of eligible English patients and the wider skin cancer community.”

The EMPOWER-CSCC-1 trial

The efficacy and safety of cemiplimab is demonstrated in EMPOWER-CSCC-1, a pivotal, open-label, multicentre, non-randomised, multi-cohort Phase 2 trial (Study 1540, NCT02760498).[4] Patients within the study were assigned to three cohort groups (Groups 1-3).⁴ The primary endpoint was confirmed Objective Response Rate (ORR) by Independent Review Committee.⁴ After median durations of follow-up of 16.5 months, 9.3 months, and 8.1 months, 49.2% of metastatic CSCC patients (Group 1) and 43.6% of locally advanced CSCC patients (Group 2) receiving weight-based dosing, and 41.1% of metastatic CSCC patients (Group 3) receiving the licensed dose of 350mg of cemiplimab every 3 weeks, had responded to treatment.⁴

The safety of cemiplimab has been evaluated in 816 patients with advanced solid malignancies who received cemiplimab monotherapy in four clinical studies.⁴ The most common adverse events (AEs) were musculoskeletal pain (29.8%), fatigue (28.1%), and rash (22.7%).⁴ AEs were serious (Grade ≥3) in 30.1% of patients.⁴ The most common Grade ≥3 AEs were anaemia (3.3%), hypertension (2.5%) and fatigue (2.3%).⁴  Immune related adverse reactions occurred in 22.1% of patients, with hypothyroidism (7.5%), hyperthyroidism (3.3%) and pneumonitis (3.2%) the most common.⁴

About CSCC

CSCC is the second most common skin cancer in the UK and accounts for 23% of all non-melanoma skin cancers.[5] The incidence of non-melanoma skin cancer is rising and is estimated to continue to do so until 2040.[6] Although the majority of patients with CSCC have a good prognosis if diagnosed and managed early, the cancer can be especially difficult to treat when it progresses to advanced stages, with the median overall survival rate at less than two years for metastatic cases.[7]

Fleur Chandler

Head of Market Access, Sanofi UK & Ireland

“We’re thrilled to have worked closely with NICE and NHS England to reach this point whereby cemiplimab has transitioned from interim CDF funding into routine NHS commissioning, a move that ensures eligible patients in England have long-term access to this innovative treatment. The increasing incidence of non-melanoma skin cancer forecast over the coming decades makes it essential that we provide patients with viable treatment options at every stage of disease, as we look to improve outcomes whilst maintaining quality of life. We look forward to continuing discussions with other devolved nations throughout the UK.”

About LIBTAYO^® (cemiplimab)

Cemiplimab is a fully-human lgG4 monoclonal antibody targeting the immune checkpoint

receptor PD-1 (programmed cell death protein-1).⁴ The European Commission granted conditional marketing authorisation for cemiplimab for the treatment of adult patients with  metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation on 1 July 2019.[8]

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

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and potentially life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of our ambitions.

Contacts

Nick Murphy | +44 (0) 7591 596385 | nick.murphy@sanofi.com

Barney Mayles | +44 (0) 7936 768568 | sanofiuk@anthem-pr.com

References

[1] NICE. Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma. Available at: https://www.nice.org.uk/guidance/ta592. Accessed May 2022.

[2] Kwiatkowska et al. An updated report on the incidence and epidemiological trends of keratinocyte cancers in the United Kingdom 2013–2018. Skin Health and Disease 2021; 1:4

[3] Venables, Z et al. Nationwide Incidence of Metastatic Cutaneous Squamous Cell Carcinoma in England. JAMA Dermatology 2018.

[4] EMC. LIBTAYO 350 mg concentrate for solution for infusion – SmPC. Available at: https://www.medicines.org.uk/emc/product/10438#gref. Accessed May 2022.

[5] British Skin Foundation. Squamous cell carcinoma. Available at: https://knowyourskin.britishskinfoundation.org.uk/condition/squamous-cell-carcinoma/. Accessed May 2022.

[6] Newlands, C., et al. 2016. Non-melanoma skin cancer: United Kingdom National Multidisciplinary Guidelines. The Journal of Laryngology and Otology, 130(S2), pp.S125-S132.

[7] Nice.org.uk. 2018. Single Technology Appraisal - Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma [ID1367]. Available at: https://www.nice.org.uk/guidance/ta592/evidence/committee-papers-pdf-6847944733 Accessed May 2022.

[8] Sanofi : Libtayo® (cemiplimab) approved for advanced cutaneous squamous cell carcinoma in the European Union. Sanofi.com. Available at: https://www.sanofi.com/en/media-room/press-releases/2019/2019-07-01-16-00-00. Accessed May 2022.