This study included patients with advanced basal cell skin cancer for whom hedgehog tablets (such as vismodegib) had not worked or could not be tolerated. They received the immunotherapy drug cemiplimab every 3 weeks. The tumour shrank in about 1 in every 3 patients with locally advanced disease and about 1 in every 5 with spread disease. Nearly half of patients had a severe side effect, but there were no deaths caused by the drug.
Locally advanced or metastatic BCC previously treated with a hedgehog inhibitor, or when these drugs are not appropriate
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cemiplimab | 350 mg | IV infusion over 30 minutes | Day 1 every 3 weeks |
Per the FDA label. Evidence:; second-line place in therapy:.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Cemiplimab 350 mg IV every 3 weeks for up to 93 weeks, or until progression or unacceptable toxicity. (Approved dose in the FDA label: 350 mg every 3 weeks for up to 24 months.)
Source of the regimen details: Abstract of the paper (Lancet Oncol 2021), abstract of the final analysis of the metastatic group (Ann Oncol 2024) and the FDA label for Libtayo (section 14.2)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults aged 18 or older with ECOG 0 or 1 and histologically confirmed metastatic (group 1) or locally advanced (group 2) basal cell carcinoma who had progressed on or were intolerant of a hedgehog inhibitor, or had no better than stable disease after 9 months of it. According to the FDA label, patients with autoimmune disease requiring systemic immunosuppressive treatment within the previous 5 years, a history of solid organ transplant or prior anti-PD-1 or anti-PD-L1 therapy were excluded.
Primary endpoint: objective response on independent central review. Secondary endpoints: duration of response, investigator-assessed response, progression-free survival, overall survival, complete response and safety. Analysis by intention to treat.
Locally advanced: grade 3 to 4 adverse events in 48% (most common: hypertension 5% and colitis 5%); serious adverse events 35%; no treatment-related deaths. Metastatic: most common adverse events fatigue 43% and diarrhoea 37%; no treatment-related deaths.
The basis of FDA approval of cemiplimab in locally advanced or metastatic BCC after a hedgehog inhibitor or when these drugs are not appropriate (350 mg every 3 weeks for up to 24 months). The 2023 EADO guideline considers cemiplimab the second-line treatment for advanced BCC after progression on, contraindication to or intolerance of a hedgehog inhibitor.
Single-arm and non-randomised; the response rate was moderate and complete responses were few. Follow-up of the metastatic group in the final analysis was short (median 8 months). Patients with an organ transplant or autoimmune disease needing treatment were not enrolled.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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