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 tumor histology.
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. Treatment options are also more limited in advanced stages. In Scotland, only 20% of women diagnosed with stage IV cervical cancer will survive five years.
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 tumor histology -- a significant advance for women who currently have limited options.”
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.”
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.
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.
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).
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).
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 anemia (5%), hypertension (3%), fatigue (3%), urinary tract infection (2%), hepatitis (2%), musculoskeletal pain (2%), rash (2%), dyspnea (1%) and pneumonitis (1%).
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