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New Indication: Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma

New Indication: Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma
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 Sep 12.

Gross ND, Miller DM, Khushalani NI, et al. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma

https://doi.org/10.1056/nejmoa2209813

Reviewed by Hasan Çağrı Yıldırım, MD on Sep 27, 2022

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