In this study, patients with large squamous cell skin cancer, or cancer that had spread to the lymph nodes but could still be removed by surgery, received up to 4 doses of the immunotherapy drug cemiplimab before surgery. In about half of them, no living cancer cells were left in the tissue that was removed, and none of these patients had their cancer come back in the following years. This approach is not yet an approved treatment and needs to be confirmed in comparative studies.
Resectable cSCC of stage II (primary tumour at least 3 cm), III or IV without distant metastasis, ECOG 0 or 1; off-label, ideally within a trial or after tumour board discussion
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cemiplimab | 350 mg | IV | Every 3 weeks (days 1, 22, 43 and 64) |
Dose and schedule as in the phase 2 trial; this use is not in the FDA label. Imaging at weeks 6 and 12 to detect progression; 11% of patients did not have surgery within the planned window. Final follow-up:.
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 4 doses over 12 weeks (days 1, 22, 43 and 64), followed by curative-intent surgery on days 75 to 100. Imaging at baseline, week 6 and week 12. After surgery, at the investigator’s discretion: adjuvant cemiplimab for up to 48 weeks, adjuvant radiotherapy or observation only. 78% of patients received all 4 doses.
Source of the regimen details: Abstract and full text of the paper (N Engl J Med 2022; author manuscript in PMC), abstracts of Lancet Oncol 2023 and J Clin Oncol 2026
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 resectable stage II, III or IV cSCC without distant metastasis (M0) for whom primary surgery would be recommended in routine practice; in stage II the primary tumour was at least 3 cm. Head and neck tumours were staged with AJCC 8th edition and other sites with UICC 9th edition. Adequate organ function, at least one measurable lesion by RECIST 1.1 and ECOG 0 or 1; previous radiotherapy for cSCC was an exclusion criterion. Median age 73 years (24 to 93); 85% men; 91% head and neck tumours; stage III in 48% and stage IV (M0) in 46%; nodal metastases in 60%.
Primary endpoint: pathological complete response (no viable tumour cells in the surgical specimen) on independent central laboratory review; null hypothesis 25%. Key secondary endpoints: major pathological response (viable tumour cells 10% or less), the same responses on local laboratory assessment, objective response on imaging, and adverse events. Event-free, disease-free and overall survival in the follow-up reports.
Adverse events of any grade in 87% (most common: fatigue 30%, and diarrhoea, nausea and maculopapular rash 14% each); grade 3 in 10%, grade 4 in 3% and grade 5 in 5% (grade 3 or higher 18% overall). Treatment-related adverse events 72%; immune-related adverse events 15% (grade 3 in 4%). 4 fatal events, including a fatal exacerbation of heart failure in a 93-year-old woman considered possibly related to treatment; three deaths were most likely related to underlying heart disease. In the final analysis, no new grade 3 or higher adverse events occurred.
Showed that anti-PD-1 therapy before surgery gives a high pathological response rate in high-risk resectable cSCC and might allow less damaging surgery; pathological response was associated with excellent long-term outcomes. This use is not in the FDA label for cemiplimab, and the 2026 EADO guideline does not list it among standard treatments; use outside a trial should be discussed in a tumour board.
No control group or randomisation (possible selection bias); most participants were white men. The optimal duration of neoadjuvant treatment and the need for treatment after surgery are unclear, and post-operative treatment was at the investigator’s discretion. 11% of patients did not have surgery within the planned window, and several cardiac deaths occurred in older patients with coexisting illnesses.
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.
Who are you reading this site as?
Your choice applies to every page; change it any time from the bottom of the page.
Type to search...