Instructions for cimepilimab

1. Common name:Cemiplimab

Product name:Libtayo

All names:Cemiplimab, Libtayo, Cemiplimab

2. Indications:

Cemiplimab is indicated to treat the following conditions:

1. Cutaneous squamous cell carcinoma (CSCC): It is suitable for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not suitable for radical surgery or radical radiotherapy.

2. Basal cell carcinoma (BCC): Indicated for the treatment of patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have been previously treated withhedgehog pathway inhibitors, or where hedgehog pathway inhibitors are not suitable for these patients.

3. Non-small cell lung cancer (NSCLC):

(1) It can be combined with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) without EGFR, ALK or ROS1 abnormalities, as follows: locally advanced, patients are not suitable for surgical resection or definitive chemoradiotherapy, or metastatic.

(2) Indicated as a single agent for the first-line treatment of adult NSCLC patients whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥50%], no EGFR, ALK or ROS1 abnormalities, and are: locally advanced, the patient is not suitable for surgical resection or definitive chemoradiotherapy, or is metastatic.

3. Usage and dosage:

1. Recommended dosage:

(1) Locally advanced or metastatic BCC and locally advanced or metastatic CSCC: The recommended dose of cimepilimab is 350 mg as an intravenous infusion every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months;

(2) NSCLC: The recommended dose of cimepilimab is 350 mg as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity occurs.

2. Dose adjustment: It is not recommended to reduce the dose of cimipilimab. In general, cimepilimab should be discontinued for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue cimipilimab due to life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions requiring systemic immunosuppressive therapy, or inability to reduce the corticosteroid dose to 10 mg or less prednisone equivalents per day within 12 weeks of initiating steroids.

4. Adverse reactions:

In clinical studies of cimepilimab , the most common adverse reactions (≥15%) were fatigue, musculoskeletal pain, rash, diarrhea, and anemia; the most common grade 3-4 laboratory abnormalities (≥2%) were lymphopenia, anemia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, hypokalemia, hyperkalemia, and increased alanine aminotransferase.

5. Supply and storage:

Cimepilimab injection is a clear to slightly opalescent, colorless to light yellow solution that may contain trace amounts of translucent to white particles. It is packaged in a carton containing 1 single-dose vial of 350 mg/7mL (50 mg/mL) (Store in the original carton refrigerated at 2°C to 8°C [36°F to 46°F]). Avoid light. Do not freeze or shake.

6. Special groups:

1. Women: According to its mechanism of action, the use of cimepilimab by pregnant women can cause harm to the fetus; therefore, it is recommended that women of childbearing potential use effective contraceptive measures during treatment and at least 4 months after the last dose; they should not breastfeed during treatment and at least 4 months after the last dose.

7. Mechanism of action:

Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligand occurs in some tumors, and signaling through this pathway may contribute to suppression of active T cell immune surveillance of tumors. Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated suppression of immune responses, including anti-tumor immune responses. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4347ae1f-d397-4f18-8b70-03897e1c054a