Multinational phase 2 study of neoadjuvant cemiplimab and surgery for stage II-IV cutaneous squamous cell carcinoma

A multinational phase 2 trial evaluated neoadjuvant cemiplimab and surgery for resectable stage II-IV cutaneous squamous cell carcinoma. Rates of pathologic complete response (51%) and major pathologic response (13%) were reported previously. After surgery, per investigator discretion, patients received either adjuvant cemiplimab for up to 48 weeks, radiotherapy, or observation alone. Median follow-up was 18.7 months. Among all patients, the estimated 12-month event-free survival rate was 89%, the estimated 12-months disease-free survival rate was 92%, and the estimated 12-months overall survival rate was 92%. There were no grade 4 or 5 adverse events. The authors conclude that for patients with resectable stage II-IV cutaneous squamous cell carcinoma, neoadjuvant cemiplimab followed by surgery might be a potential treatment option.