Retrospective study of nonoperative management of locally advanced resectable CSCC of head and neck with cemiplimab

Neoadjuvant PD-1 blockade has shown efficacy before surgery in patients with head and neck cutaneous squamous cell carcinoma (CSCC). The potential of PD-1 blockade as definitive, nonoperative therapy is not clear. A retrospective study (2018 to 2023) at Memorial Sloan Kettering Cancer Center (New York, NY) evaluated neoadjuvant cemiplimab followed by surgery versus cemiplimab monotherapy without surgery among patients with resectable stage III/IV head and neck CSCC. The primary endpoint was the objective radiologic response rate and clinical response rate. Fifty-one patients received cemiplimab monotherapy alone (median age 78.8 years) and 21 received neoadjuvant cemiplimab followed by surgery (median age 73 years). The 2-year disease-specific survival (DSS) and progression-free probability (PFP) rates for cemiplimab monotherapy were 90% (95% CI 80-100) and 82% (72-94), respectively. The 2-year DSS and PFP rates for neoadjuvant cemiplimab with surgery were 95% (95% CI 86-100) and 78% (62-100), respectively. Tumor-infiltratin lymphocytes (TILs) were higher in patients with complete response or partial response than in patients with stable disease or progressive disease, with absent TILs more frequent in nonresponders. Tumor mutational burden was higher in completer response and partial response than in progressive disease. The authors conclude that in this retrospective cohort, definitive-intent cemiplimab monotherapy was associated with durable disease control in selected patients with locally advanced resectable head and neck CSCC.