# Neoadjuvant cemiplimab for stage II to IV cutaneous squamous cell carcinoma

Source: https://onco.cc/key-papers/paper-gross-neoadjuvant-cemiplimab-cscc-nejm-2022/  
OnCo record `paper-gross-neoadjuvant-cemiplimab-cscc-nejm-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Giving four doses of cemiplimab before surgery for resectable cutaneous squamous cell carcinoma eliminated all viable tumour in half of patients and left only minimal residual disease in another 13 percent, opening the way to smaller operations and less radiotherapy.

## Summary

Phase 2 study of 79 patients with resectable stage II to IV (M0) cutaneous squamous cell carcinoma treated with up to four doses of neoadjuvant cemiplimab followed by surgery.

Pathological complete response was 50.6 percent and major pathological response (10 percent or less viable tumour) a further 12.7 percent; radiological response underestimated pathological response, and adverse events were consistent with PD-1 blockade.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2022
- DOI: 10.1056/NEJMoa2209813
- Authors: Gross ND, Miller DM, Khushalani NI, et al.
- Findings: Pathological complete response 50.6 percent; major pathological response 12.7 percent.; Objective radiological response 68.4 percent.
- What it means: Neoadjuvant cemiplimab is now used to shrink large or function-threatening cutaneous squamous cell carcinomas before surgery, and pathological response is being studied as a guide to omitting adjuvant radiotherapy.
- Caveats: Single-arm; long-term recurrence-free survival data are maturing.; Surgical de-escalation after complete response is not yet standard.

## Sources

- N Engl J Med 2022: https://doi.org/10.1056/NEJMoa2209813
- PubMed: https://pubmed.ncbi.nlm.nih.gov/36094839/

## Connected records

- cancers: [Advanced cutaneous squamous cell carcinoma](https://onco.cc/cancers/advanced-cutaneous-scc/)
- drugs: [Cemiplimab](https://onco.cc/drugs/cemiplimab/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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