Cemiplimab in high risk cutaneous squamous-cell carcinoma

In a phase 3 randomized trial recently published on The New England Journal of Medicine, adjuvant cemiplimab therapy led to longer disease-free survival than placebo among patients at high risk for recurrence of cutaneous squamous-cell carcinoma.

In the phase 3 C-POST trial a total of 415 patients with local or regional cutaneous squamous-cell carcinoma, after surgical resection and postoperative radiotherapy, at high risk for recurrence, were randomized to receive cemiplimab, a PD-1 antibody, or placebo. After a median follow-up of 24 months, disease-free survival was superior with cemiplimab versus placebo, with an estimated disease-free survival of 87,1% with cemiplimab and 64,1% with placebo. Cemiplimab led to lower risks of locoregional and distant recurrence; adverse events of grade 3 or higher occurred in 23.9% of the patients who received cemiplimab and in 14.2% of those who received placebo. Discontinuation of the regimen due to adverse events occurred in 9.8% of the patients in the cemiplimab group and in 1,5% of placebo group. «In this primary analysis of the phase 3 C-POST trial, disease-free survival was significantly longer with adjuvant cemiplimab therapy than with placebo among patients at high risk for recurrence of cutaneous squamous-cell carcinoma after definitive local therapy», authors say. «The risk of disease recurrence or death was 68% lower with cemiplimab than with placebo. The risk of locoregional recurrence was 80% lower with adjuvant cemiplimab therapy than with placebo, and the risk of distant recurrence was 65% lower. Moreover, the safety profile of cemiplimab in the context of adjuvant therapy was consistent with the known safety profile of cemiplimab monotherapy in the context of advanced or metastatic disease. In this trial, adjuvant cemiplimab therapy led to a large benefit, as compared with placebo, with regard to disease-free survival among patients at high risk for recurrence of cutaneous squamous-cell carcinoma», authors conclude.