Neoadjuvant cemiplimab in patients with stage II-IV cutaneous squamous cell carcinoma

Описание: Neil Gross, MD, FACS, University of Texas MD Anderson Cancer Center, Houston, TX, shares results on a primary analysis of a Phase II study (NCT04154943) investigating neoadjuvant cemiplimab in patients with stage II–IV cutaneous squamous cell carcinoma (CSCC). The primary endpoint was pathologic complete response (pCR) rate per independent central pathologic review (ICPR). Key secondary endpoints include major pathologic response (MPR) per independent central pathologic review (ICPR), objective response rate (ORR), safety and tolerability. A total of 79 patients were enrolled, 70 underwent surgery. The study met its primary endpoint of pCR, which was observed in 50.6% of patients. ORR was 68.4%. 4 patients died due to adverse events (AEs). The pCR together with MPR demonstrated in patients stage II-IV CSCC in this trial is the highest observed in a multicenter anti-PD-1 neoadjuvant monotherapy study for any solid tumor type. The safety profile of neoadjuvant cemiplimab was consistent with previous reports of anti-PD-1 monotherapy. This interview took place at the European Society for Medical Oncology (ESMO) 2022 Congress in Paris, France.