Scottish Medicines Consortium Accepts Libtayo®▼ (cemiplimab) as First Approved Drug Treatment for Advanced Cutaneous Squamous Cell Carcinoma in Scotland

Scottish Medicines Consortium Accepts Libtayo^®▼ (cemiplimab) as First Approved Drug Treatment for Advanced Cutaneous Squamous Cell Carcinoma in Scotland

 

Cemiplimab is the first and only approved systemic treatment option available on the National Health Service in Scotland for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation[i]

 

Cutaneous squamous cell carcinoma is the second most common form of skin cancer in Scotland, with incidence rates continuing to rise each year[ii]^,[iii]

 

The Scottish Medicines Consortium decision is based on data from the open-label, non-randomised pivotal EMPOWER-CSCC 1 trial, which demonstrated substantial and durable responses, and an acceptable safety profile, following treatment with cemiplimab[iv]

 

Uxbridge, UK, December 11, 2023 – Regeneron UK Limited today announced that the Scottish Medicines Consortium (SMC) has accepted Libtayo^® (cemiplimab) for use as monotherapy treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only systemic treatment available on the National Health Service (NHS) in Scotland to treat advanced CSCC.¹

 

Cemiplimab was previously accepted on an interim basis for advanced CSCC in February 2020 after being considered through the SMC’s Patient and Clinician Engagement (PACE) process as an orphan-equivalent and end of life medicine.[v] Following reassessment by the SMC, cemiplimab was accepted for routine use, providing full access on the NHS in Scotland to eligible adults with advanced CSCC.¹

 

"Advanced cutaneous squamous cell carcinoma, or CSCC, is serious and difficult to treat, with a median overall survival of under one year.* There is a significant unmet need for a systemic option for cases that cannot be managed through surgery or radiation,” said Stefano Schipani, M.D., Clinical Oncologist, Beatson West of Scotland Cancer Centre.[vi] "With no other approved drug treatments available for advanced CSCC in Scotland, the SMC’s decision to accept cemiplimab is a positive development for patients who have limited treatment options.”⁵

 

CSCC, a form of non-melanoma skin cancer, impacts an estimated 3,000 people in Scotland each year, with the incidence continuing to rise.³ Across the United Kingdom (UK), an average of approximately 28,000 people are diagnosed with CSCC annually, making it the second most common skin cancer.^2,[vii] When CSCC invades deeper layers of the skin or adjacent tissues, it is categorised as locally advanced.[viii] Once it spreads to other distant parts of the body, it is considered metastatic.[ix] Approximately 5% of CSCC cases will develop into locally advanced or metastatic disease, which is associated with a poor prognosis and a significant impact on quality of life.⁵

 

For further information about cemiplimab, please refer to the summary of product characteristics, available here.

 

*Median overall survival with best supportive care or platinum-based chemotherapy is 8-12 months.

 

About Cemiplimab

Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune^® technology.^4,[x] By binding to PD-1, cemiplimab has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.⁴ In the UK and other countries, cemiplimab is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced CSCC, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer.⁴ As of July 1, 2022, cemiplimab is developed and marketed globally by Regeneron.[xi]

 

Cemiplimab approval is based on data from the pivotal, open-label, multi-centre, non-randomised Phase 2 trial known as EMPOWER-CSCC 1 (Study 1540). Patients within the study were assigned to three cohort groups (Groups 1, 2 and 3). The primary endpoint was confirmed objective response rate (ORR) by independent review committee. With a median duration of follow-up of 17 months (Group 1), 9 months (Group 2) and 8 months (Group 3), the ORR was 51% for metastatic CSCC patients (Group 1) and 50% for locally advanced CSCC patients (Group 2) treated with weight-based dosing, as well as 46% for metastatic CSCC patients (Group 3) treated with the licensed dose of 350 mg every three weeks.⁴

 

The safety of cemiplimab has been evaluated in 1,281 patients with advanced solid malignancies who received cemiplimab monotherapy in five clinical studies. The most common immune-mediated adverse reactions were hypothyroidism (7%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and skin adverse reactions (2%). Adverse reactions were serious in 32% of patients and led to permanent discontinuation in 9% of patients. Grade 3 or higher adverse reactions occurring in >1% of patients were anaemia (5%), hypertension (3%), fatigue (3%), urinary tract infection (2%), hepatitis (2%), musculoskeletal pain (2%), rash (2%), dyspnoea (1%) and pneumonitis (1%).⁴

 

Cemiplimab is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches, for other solid tumours and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

 

About Regeneron in Cancer

We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.

 

Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumours and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor cemiplimab serves as the backbone of many of our investigational combinations.

 

To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.

 

About Regeneron
Regeneron is a leading biotechnology company that invents, develops and commercialises life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Regeneron’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.

 

Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite^® technologies, such as VelocImmune^®, which uses unique genetically humanised mice to produce optimised fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center^®, which is conducting one of the largest genetics sequencing efforts in the world.

 

For additional information about Regeneron, please visit https://www.regeneron.co.uk/.

 

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Libtayo^® (cemiplimab) for the treatment of advanced cutaneous squamous cell carcinoma; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products (such as Libtayo as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches, for other solid tumours and blood cancers); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as Libtayo) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA^® (aflibercept) Injection and REGEN-COV^® (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022 and its Form 10-Q for the quarterly period ended September 30, 2023. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

 

Contacts:   Media Relations                               Aditi Bhandari Tel: +1 914-374-1841 aditi.bhandari@regeneron.com

Investor Relations Vesna Tosic Tel: +1 914-847-5443 vesna.tosic@regeneron.com

 

 

References

 

¹ Scottish Medicines Consortium. cemiplimab (Libtayo). Available from:  https://www.scottishmedicines.org.uk/medicines-advice/cemiplimab-libtayo-reassessment-smc2584/ . Last accessed: December 2023.

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 NHS Scotland. Scottish Referral Guidelines for Suspected Cancer. Skin Cancers. Available from: https://www.cancerreferral.scot.nhs.uk/skin-cancers/?alttemplate=guideline. Last accessed: December 2023.

⁴ Cemiplimab SmPC. Available at: https://www.medicines.org.uk/emc/product/10438/smpc#gref. Last accessed: December 2023.

5 Scottish Medicines Consortium. Libtayo Detailed Advice. 10 January 2020. Available from: https://www.scottishmedicines.org.uk/media/5069/cemiplimab-libtayo-final-jan-2020-for-website.pdf. Last accessed: December 2023.

6 NHS National Institute for Health Research (NIHR). NIHR Innovation Observatory Evidence Briefing: October 2017. Cemiplimab for advanced cutaneous squamous cell carcinoma – first line. Available from: https://www.io.nihr.ac.uk/wp-content/uploads/2022/01/12662-Cemiplimab-for-advanced-cSCC.pdf. Last accessed: December 2023.

7 British Association of Dermatology. Squamous Cell Carcinoma. Available from: https://www.bad.org.uk/pils/squamous-cell-carcinoma/. Last accessed: December 2023.

8 Migden M R, et al. Emerging Trends in the Treatment of Advanced Basal Cell Carcinoma. Cancer Treat Rev. 2018;64:1-10.

9 Burton KA, et al. Cutaneous Squamous Cell Carcinoma: A Review of High-Risk and Metastatic Disease. Am J Clin Dermatol. 2016;17(5):491-508.

¹⁰ 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. Mol Cancer Ther. 2017;16(5):861-870.

1¹ Regeneron Press Release. Regeneron completes purchase of Sanofi’s stake in Libtayo^® (cemiplimab). July 1, 2022. Available at: https://investor.regeneron.com/news-releases/news-release-details/regeneron-completes-purchase-sanofis-stake-libtayor-cemiplimab. Last accessed: December 2023.

 

 

 

---

[i] Scottish Medicines Consortium. cemiplimab (Libtayo). Available from:                                                     https://www.scottishmedicines.org.uk/medicines-advice/cemiplimab-libtayo-reassessment-smc2584/ . Last accessed: December 2023.

[ii] 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.

[iii] NHS Scotland. Scottish Referral Guidelines for Suspected Cancer. Skin Cancers. Available from: https://www.cancerreferral.scot.nhs.uk/skin-cancers/?alttemplate=guideline. Last accessed: December 2023.

[iv] Cemiplimab SmPC. Available at: https://www.medicines.org.uk/emc/product/10438/smpc#gref. Last accessed: December 2023.

[v] Scottish Medicines Consortium. Libtayo Detailed Advice. 10 January 2020. Available from: https://www.scottishmedicines.org.uk/media/5069/cemiplimab-libtayo-final-jan-2020-for-website.pdf. Last accessed: December 2023.

[vi] NHS National Institute for Health Research (NIHR). NIHR Innovation Observatory Evidence Briefing: October 2017. Cemiplimab for advanced cutaneous squamous cell carcinoma – first line. Available from: https://www.io.nihr.ac.uk/wp-content/uploads/2022/01/12662-Cemiplimab-for-advanced-cSCC.pdf. Last accessed: December 2023.

[vii] British Association of Dermatology. Squamous Cell Carcinoma. Available from: https://www.bad.org.uk/pils/squamous-cell-carcinoma/. Last accessed: December 2023.

[viii] Migden M R, et al. Emerging Trends in the Treatment of Advanced Basal Cell Carcinoma. Cancer Treat Rev. 2018;64:1-10.

[ix] Burton KA, et al. Cutaneous Squamous Cell Carcinoma: A Review of High-Risk and Metastatic Disease. Am J Clin Dermatol. 2016;17(5):491-508.

[x] 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. Mol Cancer Ther. 2017;16(5):861-870.

[xi] Regeneron Press Release. Regeneron completes purchase of Sanofi’s stake in Libtayo^® (cemiplimab). July 1, 2022. Available at: https://investor.regeneron.com/news-releases/news-release-details/regeneron-completes-purchase-sanofis-stake-libtayor-cemiplimab. Last accessed: December 2023.