Libtayo®▼ (cemiplimab) Now Available on the National Health Service in Scotland for Patients with Recurrent or Metastatic Cervical Cancer

Regeneron UK Limited today announced that the Scottish Medicines Consortium (SMC) has accepted Libtayo^® (cemiplimab) for use on the National Health Service as a second-line monotherapy treatment for adults with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy, irrespective of PD-L1 expression level or tumour histology.¹

Although cervical cancer is often curable when detected early and effectively managed, advanced or metastatic disease – when the cancer spreads from the cervix to other distant parts of the body -- has a poor prognosis and can significantly impact a patient’s quality of life.^2,3 Treatment options are also more limited in advanced stages.^2-4 In Scotland, only 20% of women diagnosed with stage IV cervical cancer will survive five years.⁵

“The acceptance of cemiplimab by the SMC marks the availability of the first immunotherapy for recurrent or metastatic cervical cancer on or after platinum-based chemotherapy, irrespective of PD-L1 expression level or tumour histology -- a significant advance for women who currently have limited options,”^1,4,6,7 said James Winterman, Regeneron UK and Ireland Country Manager, Oncology. “The rate of women diagnosed with cervical cancer each year is significantly higher in Scotland compared to the UK average, and cemiplimab could offer a new standard of care for patients in Scotland who progress on chemotherapy.”^8-10  

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.¹¹ By binding to PD-1, cemiplimab has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.¹¹

SMC acceptance is based on data from the open-label, multi-centre, randomised Phase 3 trial known as EMPOWER-Cervical 1. Patients who had disease progression after first-line platinum-containing chemotherapy were randomly assigned to receive cemiplimab (350 mg every three weeks) or investigator's choice of single-agent chemotherapy. Patients were allowed to enrol regardless of PD-L1 expression status; in the overall population, 78% of patients had squamous cell carcinoma (SCC) and 22% had adenocarcinoma or adenosquamous carcinoma.¹²

In the overall trial population (N=608), patients treated with cemiplimab (n=304) compared to those treated with chemotherapy (n=304) experienced a significant improvement in overall survival (OS) and objective response rate (ORR). This included:

• Median OS of 12 months vs. 8.5 months for chemotherapy (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.56-0.84; p=0.00011).
• ORR of 16% vs. 6% for chemotherapy (95% CI: 12.5-21 vs. 4-10).¹²

Among patients with SCC histology (n=477), patients who received cemiplimab had a median OS of 11 months vs. 9 months for patients who received chemotherapy (HR: 0.73; 95% CI: 0.58-0.91; p=0.00306).¹²

The safety of cemiplimab has been evaluated in 1,281 patients with advanced solid malignancies who received cemiplimab monotherapy in five clinical trials. Immune-mediated adverse reactions (IMAEs) occurred in 21% of patients treated with cemiplimab and led to permanent discontinuation in 5% of patients. The most common IMAEs 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%).¹²

For further information about cemiplimab, please refer to the Summary of Product Characteristics.

In the UK, cemiplimab is currently indicated as follows:¹²  

• As monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation 

• As monotherapy for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI) 

• As monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: 

• locally advanced NSCLC who are not candidates for definitive chemoradiation, or
• metastatic NSCLC

• In combination with platinum-based chemotherapy for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: 

• locally advanced NSCLC who are not candidates for definitive chemoradiation, or
• metastatic NSCLC

• As monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. 

Adverse event reporting:

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk, via the free yellow card app in the Google Play or Apple App Store or via clinical IT systems for healthcare professionals. Alternatively, you can call 0800 731 6789 for free (Monday to Friday between 9am and 5pm). Suspected adverse events should also be reported to Regeneron Medical Information on 0800 917 7120 or via email to medical.information_global@regeneron.com.

About Regeneron in Cancer

We aspire to turn revolutionary discoveries into medicines with the aim to 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 potentially be flexibly combined to investigate potentially transformative treatments for patients.

About Regeneron
Regeneron is a leading biotechnology company dedicated to inventing, developing and commercialising medicines for people with serious diseases.  Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

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

References

¹ Scottish Medicines Consortium. cemiplimab concentrate for solution for infusion (Libtayo®). Available at: https://scottishmedicines.org.uk/media/8944/cemiplimab-libtayo-final-jan-2025-for-website.pdf. Last Accessed: February 7, 2025.

² Cancer Research UK. What is advanced cervical cancer? Available at: https://www.cancerresearchuk.org/about-cancer/cervical-cancer/advanced/about. Last Accessed: February 7, 2025.

³ NHS. Treatment for Cervical Cancer. Available at: https://www.nhs.uk/conditions/cervical-cancer/treatment/.Last Accessed: February 7, 2025.

⁴ Cancer Research UK. Treatment options for cervical cancer. Available at: https://www.cancerresearchuk.org/about-cancer/cervical-cancer/treatment/treatment-decisions. Last Accessed: February 7, 2025.

⁵ NHS inform. Cervical Cancer. Available at: https://www.nhsinform.scot/illnesses-and-conditions/cancer/cancer-types-in-adults/cervical-cancer/. Last Accessed: February 7, 2025.

⁶ Scottish Medicines Consortium. pembrolizumab (Keytruda). Available at: https://scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-cc-full-smc2501/. Last Accessed: February 7, 2025.

⁷ Cibula D, et al. ESGO/ESTRO/ESP Guidelines for the management of patients with cervical cancer - Update 2023. Int J Gynecol Cancer.2023; 33:649–666.9 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.

⁸ Public Health Scotland. Cervical cancer - Patients diagnosed from October 2020 to September 2023. Available at:  https://publichealthscotland.scot/publications/cervical-cancer/cervical-cancer-quality-performance-indicators-patients-diagnosed-from-october-2020-to-september-2023/. Last Accessed: February 7, 2025.

⁹ Cancer Research UK. Cervical cancer incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/cervical-cancer/incidence#heading-Zero. Last Accessed: February 7, 2025.

¹⁰ Cancer Research UK. Cervical cancer statistics. Available at https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/cervical-cancer. Last Accessed: February 7, 2025.

 ¹¹ 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.   

¹² Cemiplimab SmPC. Available at: https://www.medicines.org.uk/emc/product/10438/smpc/print. Last Accessed: February 7, 2025.