Scottish Medicines Consortium approves Libtayo as a second-line treatment for advanced cervical cancer

Scottish Medicines Consortium approves Libtayo as a second-line treatment for advanced cervical cancer

Regeneron UK Limited today announced that the Scottish Medicines Consortium (SMC) has accepted Libtayo® (cemiplimab) for the National Health Service as a second-line monotherapy treatment for adults with recurrent chemotherapy, errant or metastatic cervical cancer and tumor expression or tumor histology as a second-line treatment.

Although cervical cancer is often curable if treated early and effectively, 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 limited even in advanced stages. In Scotland only 20% of women 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, regardless of the expression level or tumor histology of PD-L1—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 provide a new standard of care for patients in Scotland progressing to chemotherapy.”

About cemiplimab

Cemiplimab is a fully human monoclonal antibody that targets the PD-1 immune checkpoint receptor on T cells and was invented using Regeneron's proprietary technologyVelocimmune®Technology.11 By binding to PD-1, cemiplimab has been shown to prevent cancer cells from suppressing the PD-1 pathway to suppress T cell activation.

The SMC acceptance is based on data from the open-label, multicenter, randomized Phase 3 trial called Empower-Cervical 1. Patients with disease progression after first-line platinum-containing chemotherapy were randomly assigned to receive cemiplimab (350 mg) or investigational chemotherapy. Patients were allowed to enroll regardless of PD-L1 expression status. In the general population, 78% of patients had squamous cell carcinoma (SCC) and 22% had adenocarcinoma or adenosquamous carcinoma.

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

• Median OS von 12 Monaten gegenüber 8,5 Monaten für die Chemotherapie (Hazard Ratio [HR]: 0,69; 95% Konfidenzintervall [CI]: 0,56-0,84; p = 0,00011).
• ORR von 16% gegenüber 6% für die Chemotherapie (95% CI: 12,5-21 gegenüber 4-10).

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

The safety of cemiplimab was evaluated in 1,281 patients with advanced solid malignancies who received cemiplimab monotherapy in five clinical trials. Immune-related adverse reactions (IMAEs) occurred in 21% of cemiplimab-treated patients and resulted in permanent discontinuation in 5% of patients. The most common IMAEs were hypothyroidism (7%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and 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 included 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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