# PD-1 blockade with cemiplimab in advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1)

Source: https://onco.cc/key-papers/paper-empower-cscc-1-cemiplimab-migden-nejm-2018/  
OnCo record `paper-empower-cscc-1-cemiplimab-migden-nejm-2018` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Cemiplimab shrank tumours in about half of patients with metastatic or locally advanced cutaneous squamous cell carcinoma, a highly mutated skin cancer with almost no previous treatment options, leading to the first approval for the disease.

## Summary

Phase 1 expansion cohort (26 patients) and phase 2 study (59 patients) of cemiplimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma not amenable to curative surgery or radiotherapy.

Objective response was 50 percent in the phase 1 cohort and 47 percent in the phase 2 metastatic cohort, with most responses durable beyond six months and typical immune-related toxicity.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2018
- DOI: 10.1056/NEJMoa1805131
- Authors: Migden MR, Rischin D, Schmults CD, et al.
- Findings: Objective response 50 percent (phase 1) and 47 percent (phase 2 metastatic cohort).; Durable responses exceeding six months in the majority of responders.
- What it means: PD-1 blockade is the first-line systemic treatment for advanced cutaneous squamous cell carcinoma, including on the lip, and cemiplimab has since moved into neoadjuvant and adjuvant use.
- Caveats: Single-arm; transplant recipients and immunosuppressed patients were excluded.

## Sources

- N Engl J Med 2018: https://doi.org/10.1056/NEJMoa1805131
- PubMed: https://pubmed.ncbi.nlm.nih.gov/29863979/

## Connected records

- cancers: [Advanced cutaneous squamous cell carcinoma](https://onco.cc/cancers/advanced-cutaneous-scc/), [Lip cancer](https://onco.cc/cancers/lip-cancer/)
- drugs: [Cemiplimab](https://onco.cc/drugs/cemiplimab/)
- trials: [EMPOWER-CSCC-1](https://onco.cc/trials/empower-cscc-1/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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