In the United States, almost 1.5 million cutaneous squamous cell cancer (cSCC) are identified yearly. Approximately 1% of cases were unresectable at the advanced stage. The Food and Drug Administration authorized Cemiplimab, an anti-PD-1 antibody, in 2018. Researchers offered real-world clinical data on outcomes and safety for patients treated with cemiplimab for metastatic and unresectable cSCC from a single institution. From September 2018 to December 2021, patients treated with cemiplimab (350 mg every 3 weeks) for advanced cSCC underwent a retrospective cohort analysis. Patient demographics, tumor features, and treatment course were all included in the data. The study comprised patients who received at least one dosage of cemiplimab and one clinic follow-up. The clinical response and the adverse events (AE) were assessed. There were 84% males (n=22) and 16% females (n=4) among the 26 patients treated, with a median age of 74 years (39-94). About 3 patients were transferred to an outside facility and were not accessible for follow-up. Thus 23 patients were included in the final analysis. Around 19 patients (73%) had locally advanced disease, whereas 7 patients (27%) had metastatic disease. The head/neck was the most prevalent site of the original tumor (85%, n=22), with the trunk/extremities (15%, n=4) accounting for the remaining instances (15%, n=4). Cemiplimab was given to patients in a median of 7 doses (range 1- 46). The median time to first response was 1.7 months, and 2.5 dosages were required on average. In 18/23 (78%) of the patients, an objective clinical response classified as complete reaction (CR) or partial response (PR) was observed, with 8/23 (35%) CR and 10/23 (44%) PR. In 6/23 (27%) of the patients showed an ongoing response with prolonged treatment. Treatment was well tolerated, with 6 of 23 (26%) adverse events (AE) being grade 1 or 2: 1 (4%) grade 1 pruritus, 5 (21.7%) grade 2 pruritus. About 1 infusion-related AE, 2 hypothyroidism, 1 dermatitis, and 1 rheumatoid arthritis flare were among the 5 grade 2 AEs. There were no AEs in grades 3-5. This was the first real-world outcomes study of advanced cSCC patients treated with cemiplimab in the United States, to the knowledge. Compared to the EMPOWER-CSCC-1 trial, the overall efficacy, response rate, and safety profile were improved.
