Libtayo (cemiplimab-rwlc)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved September 2018

Specific Treatments:

cutaneous squamous cell carcinoma

Therapeutic Areas

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General Information

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody.

Libtayo is specifically indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Libtayo is supplied as an intravenous solution. The recommended dosage is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. 

Clinical Results

FDA Approval

The FDA approval of Libtayo was based on two open label clinical trials. A total of 108 patients (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment. After a median follow-up of 8.9 months, the treatment had reduced tumor volume in 47% of the 108 CSCC patients, with 61% of responses lasting six months or longer. Response rates for metastatic CSCC specifically were 47%, including 5% with complete responses. For inoperable, locally advanced CSCC, the response rate was 49%.

Side Effects

Adverse effects associated with the use of Libtayo may include, but are not limited to, the following:

fatigue

rash

diarrhea

Mechanism of Action

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody. 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 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition 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 inhibition of the immune response, including the anti-tumor immune response.

Additional Information

For additional information regarding Libtayo or cutaneous squamous cell carcinoma, please visit https://www.libtayohcp.com/