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Adjuvant Cemiplimab vs Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma (NEJM RCT)

Rischin D, Porceddu S, Day F, et al.
New England Journal of Medicine (2025)

JC: July 2025

This NEJM randomized controlled trial evaluated adjuvant cemiplimab versus placebo in patients with high-risk cutaneous squamous cell carcinoma after surgery and optional radiation. Adjuvant cemiplimab demonstrated a significant reduction in disease recurrence, establishing adjuvant immunotherapy as a new option for high-risk cSCC.

Take-Home Messages

  • •Adjuvant cemiplimab significantly reduces disease recurrence in high-risk cSCC, changing the post-surgical management approach.
  • •This RCT provides level 1 evidence supporting adjuvant immunotherapy for high-risk cSCC, changing the standard of care.
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Topic

SCC Systemic Therapy

Adjuvant immunotherapy, cemiplimab, radiation for high-risk cSCC

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Tumor Scc

Abstract

Patients who have cutaneous squamous-cell carcinoma with high-risk features are at risk for recurrence after definitive local therapy. The benefit of systemic adjuvant therapy options has not been well established in clinical trials. In a phase 3, randomized trial, we enrolled patients with local or regional cutaneous squamous-cell carcinoma, after surgical resection and postoperative radiotherapy, at high risk for recurrence owing to nodal features (extracapsular extension with largest node ...

DOI
Literature review only. This summary is an editorial interpretation and may not reflect the complete findings of the original publication. Always refer to the full-text article for clinical decision-making.