New Indication: Neoadjuvant Cemiplimab for Cutaneous Squamous Cell Cancer


  • Study

    Phase 2, confirmatory, multicenter, nonrandomized study
    Resectable stage II, III, or IV (M0) cutaneous squamous-cell carcinoma
    Cemiplimab 350 mg/21 day (four doses) before surgery (N:79)



  • Efficacy

    pCR: 40 (51%)
    Pathological major response: 10 (13%)
    ORR (imaging): 68%



  • Safety

    Any grade AEs: 87%, serious event: 16%, fatigue:30%, diarrhea:14%, nausea:14%
    Any grade ≥3 AEs: 18%, serious event: 13%, hyponatremia:3%



  • N Engl J Med 2022; 387:1557-1568

    {“Gross N.D.et al.”}Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma

    http://doi.org/10.1056/NEJMoa2209813

    Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022