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
