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Drug · ICI · Anti-PD-1

Cemiplimab

Trade name: Libtayo. ATC L01FF06.

Cemiplimab is a fully human IgG4 anti-PD-1 monoclonal antibody. It is NICE-approved (TA802) and NHS-commissioned for advanced cutaneous SCC. It has an EMA / FDA licence for advanced basal cell carcinoma after hedgehog inhibitor failure, but is not NICE-approved for that indication in the UK at the time of writing — UK use in BCC would currently be off-pathway or via individual funding routes. Mechanism, monitoring and irAEs are essentially equivalent to other anti-PD-1 antibodies.

CurrentLast reviewed 25 March 2026

Indications

  • Locally advanced or metastatic cSCC not suitable for curative surgery or radiotherapy (NICE TA802).
  • Advanced BCC after hedgehog inhibitor failure — EMA / FDA licence; not currently NICE-approved for this indication. UK use, if considered, is via individual funding requests or specialist commissioning routes; refer to the local melanoma / skin cancer MDT.

Dosing

  • 350 mg IV every 3 weeks; infusion over 30 minutes.
  • Continue until disease progression or unacceptable toxicity.

Response

Pivotal cSCC studies (EMPOWER-CSCC-1; Migden 2018) showed objective response in approximately 50% of patients with metastatic or locally advanced cSCC, with median duration of response not reached at 2 years and prolonged disease control in many. Response rates are similar in elderly patients (median age >70 in pivotal trial).

Immune-related adverse events

Identical to other anti-PD-1 antibodies — see pembrolizumab for the comprehensive irAE table and management.

ImportantOTRs and autoimmune disease

Cemiplimab carries significant graft-rejection risk in solid organ transplant recipients (10–40% in case series) and may flare autoimmune disease. Use only with multidisciplinary transplant / rheumatology input and explicit informed consent.

Practical considerations

  • Baseline FBC, U&E, LFT, TFT, glucose, cortisol, CK; pregnancy test if applicable.
  • Cycle bloods FBC, U&E, LFT, TFT.
  • Patient holds ICI alert card.
  • Discuss with transplant team in OTRs (usually contraindicated outside specialist trial settings).

References

  1. Migden MR et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med; 2018.
  2. NICE TA802. Cemiplimab for treating advanced cutaneous squamous cell carcinoma. London: NICE; 2022.
  3. Stratigos AJ et al. Cemiplimab in advanced basal cell carcinoma after hedgehog inhibitor therapy. Lancet Oncol; 2021. (FDA / EMA evidence base for BCC; not currently NICE-approved.)

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