Libtayo

Cemiplimab (cemiplimab) instructions

Common name: cemiplimab

Trade name: Libtayo

All names: cemiplimab, cemiplimab, cemi plimab, Libtayo, cemiplimab-rwlc

Indications:

Indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced unresectable CSCC.

Single drug is used for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS ≥ 50%). These patients are not candidates for surgery or chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

Usage and dosage:

The recommended dosage of cemiplimab is 350 mg intravenously as an intravenous infusion every 3 weeks, with an infusion time of at least 30 minutes;

Treat until disease progression or unacceptable toxicity.

Adverse reactions:

The most common adverse reactions (incidence ≥20%) are fatigue, rash and diarrhea.

Taboos:

None.

Precautions:

Serious and Fatal Immune-Mediated Adverse Reactions: Immune-mediated adverse reactions can occur in any organ system or tissue and include the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrine disorders, immune-mediated dermatological adverse reactions, and immune-mediated nephritis and renal insufficiency.

Monitor for signs and symptoms of immune-mediated adverse reactions. Assess clinical chemistry, including liver and thyroid function, at baseline and cycle during treatment. Withhold or permanently discontinue LIBTAYO and administer corticosteroids based on severity of reaction.

Infusion-related reaction: Interrupt, slow down the infusion rate, or permanently discontinue the drug depending on the severity of the reaction.

Embryo-fetal toxicity: May cause fetal harm. Advise females of reproductive potential regarding the potential risk to the fetus and use of effective infections.

Storage:

Store in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F). Avoid light. Do not freeze or shake.

Mechanism of action:

Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that can bind to PD-1 and block its interaction with PD-L1 and PD-L2, releasing the suppression of immune responses mediated by the PD-1 pathway, including anti-tumor immune responses. Insyngeneic mouse tumor model, blocking PD-1 activity leads to reduced tumor growth.

Safety and Efficacy:

Efficacy was evaluated in Study 1624 (NCT03088540), a multicenter, randomized, open-label trial of 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients were randomly assigned (1:1) to receive intravenous cimepilimab 350 mg every 3 weeks mg, up to 108 weeks or platinum-based chemotherapy. The primary efficacy outcomes for each blinded independent central review (BICR) were overall survival (OS) and progression-free survival (PFS).

The trial demonstrated statistically significant improvements in OS and PFS in patients treated with cimepilimab compared with patients treated with platinum-based chemotherapy. The median OS of patients in the cimepilimab treatment group was 22.1 months (95% CI: 17.7, NE), while the median OS of patients in the chemotherapy group was 14.3 months (95% CI: 11.7, 19.2) (HR 0.68; 95%CI: 0.53, 0.87), p = 0.0022). The median PFS per BICR was 6.2 months (4.5, 8.3) in the cimepilimab group and 5.6 months (4.5, 6.1) in the chemotherapy group (HR 0.59; 95%CI: 0.49, 0.72, p <0.0001). The confirmed overall response rate (ORR) per BICR was 37% (95% CI: 32, 42) and 21% (95% CI: 17, 25) in the cimepilimab and chemotherapy arms, respectively. Eligible patients had PD-L1 expression ≥50%. Cimepilimab reduced the risk of death by 32% compared with chemotherapy in this patient population.