Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. DermNet Editor in Chief: Adjunct A/Prof Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand. Copy edited by Gus Mitchell. November 2018.
Cemiplimab (also called cemiplimab-rwlc; trade name Libtayo®) is a prescription medicine used to treat people with cutaneous squamous cell carcinoma (SCC).
In April 2018, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for cemiplimab for the treatment of patients with metastatic cutaneous SCC or with locally advanced cutaneous SCC who were not candidates for surgery.
In September 2018, the US Food and Drug Administration (FDA) approved cemiplimab as a breakthrough therapy for the treatment of patients with metastatic cutaneous SCC or locally advanced SCC who are not candidates for curative surgery or curative radiation. Regeneron and Sanofi-Aventis (New Jersey, USA) will market Libtayo® jointly in the U.S.
Cemiplimab is the first and only treatment specifically approved and available for advanced cutaneous SCC in the U.S. This drug was evaluated by the FDA under Priority Review, which is reserved for medicines that represent significant improvements in safety or efficacy in treating serious conditions.
The EMA review process is anticipated to be complete in the first half of 2019. There are currently no EMA-approved treatments for advanced cutaneous SCC.
Cemiplimab is under investigation in other malignancies. It is in Phase III development for cervical cancer and basal cell carcinoma, and in Phase II development for other cancers including glioblastoma multiforme, ovarian and prostate cancers, and acute lymphocytic leukaemia.
Regulatory applications in additional countries are also being considered for submission later in 2018. Cemiplimab is currently not available in NZ.
Cemiplimab is a human monoclonal antibody that targets the immune checkpoint receptor PD-1 (programmed cell death protein-1).
Cemiplimab is a highly selective humanised monoclonal immunoglobulin G4 (IgG4) antibody that targets checkpoint inhibitor PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway-mediated inhibition of the immune response. This includes the antitumour immune response, thereby decreasing tumour growth.
The recommended dosage of cemiplimab is 350 mg as an intravenous infusion over 30 minutes every 3 weeks until disease progression decreases or an unacceptable toxicity is reached.
Severe and fatal immune-mediated adverse reactions may necessitate withholding or discontinuing cemiplimab.
Cemiplimab should be withheld in the following conditions:
Cemiplimab should be permanently discontinued in the following conditions:
No dosage adjustment is necessary for mild or moderate renal impairment, as no clinically important effect on the exposure of cemiplimab has been observed in population pharmacokinetic studies.
No dosage adjustment is necessary for mild hepatic impairment, as no clinically important effect on the exposure of cemiplimab has been observed. There are no studies in patients with moderate or severe hepatic impairment.
No formal pharmacokinetic drug interaction studies have been conducted with cemiplimab.
In clinical trials, the most common side effects (≥ 10%) in patients receiving cemiplimab up to 3 mg/kg every 2 weeks were:
The most frequent (≥ 2%) serious adverse drug reactions observed with cemiplimab were urinary tract infection, sepsis, pneumonia, pneumonitis, and cellulitis. Cemiplimab can also cause infusion reactions including anaphylaxis.
Signs of these skin problems may include:
Before receiving treatment with cemiplimab, the healthcare provider should be informed if the patient has any of the following.
It is not known whether cemiplimab or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, mothers should discontinue nursing prior to using cemiplimab.
Females of reproductive potential should be advised to use effective contraception during treatment with cemiplimab and for at least 4 months after the last dose.
The safety and effectiveness of cemiplimab have not been established in children.
In clinical studies, of the 163 patients with metastatic and locally advanced cutaneous SCC who received cemiplimab, 72% were 65 years or older and 37% were 75 years or older. No overall differences in safety or effectiveness were observed between these and younger patients.
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