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Simple Summary: The effectiveness and safety of immune checkpoint inhibitors in the treatment of patients with advanced cutaneous squamous cell carcinoma were evaluated in a real-world population, including patients who would have typically been excluded from clinical trials. We identified 36 patients with advanced cutaneous cell carcinoma treated with immune checkpoint inhibitors between 2017 and 2022 at a single Cancer Center in Canada; ten patients had hematological malignancy, two patients had autoimmune disease on immune suppressive drug, two patients were solid organ transplant recipients, and four patients had poor performance status. The results showed that immune checkpoint inhibitors, specifically cemiplimab and pembrolizumab, were effective and safe for advanced cutaneous squamous cell carcinoma patients, regardless of age, immune status, or performance status. Immune checkpoint inhibitors exhibit a high response rate, prolonged duration of response, and a favorable toxicity profile; these characteristics position them as a preferred therapeutic option, particularly suitable for patients with comorbidities that might otherwise preclude the utilization of conventional systemic treatments. Immune checkpoint inhibitors (ICI) cemiplimab and pembrolizumab have revolutionized the treatment of advanced cutaneous squamous cell carcinoma (cSCC). We aimed to evaluate the effectiveness and safety of ICI in a real-world cSCC population, including patients with conditions that would exclude clinical trial participation. In this single-center, retrospective cohort study, we included all non-trial patients with advanced cSCC treated with ICI between 2017 and 2022. We evaluated investigator-assessed best overall response (BOR) and immune-related adverse events (irAEs). We correlated survival outcomes with age, performance status, immune status and irAEs. Of the 36 patients identified, the best overall response (BOR) to ICI was a partial response (PR) in 41.7%, a complete response (CR) in 27.8%, and stable disease in (SD) 13.9%. The progression-free survival (PFS) rate for 1 year was 58.1%; the median PFS was 21.3 months (95% CI 6.4–NE). The 1-year overall survival (OS) was 76.7%, and the median OS was 38.6 months (95% CI 25.4–NE). Immune-compromised patients, ECOG performance 2–3, and age ≥ 75 years were not significantly associated with PFS or OS. IrAE grades 3–4 were seen in 13.9% of patients. In our Canadian experience with real-world patients, ICI was an effective and safe treatment for advanced cSCC patients. Patients achieved great benefits with ICI regardless of age, immune status or ECOG performance status. We acknowledge the small sample size and retrospective methodology as the main limitations of our study. [ABSTRACT FROM AUTHOR]

Immune checkpoint inhibitor-based therapies that target ctla-4, PD-1, or the PD-1 ligand PD-L1 have received approval in Canada and many parts of the world for the treatment of melanoma, renal cell cancer, urothelial cancer, classical Hodgkin lymphoma, and non-small-cell lung cancer. However only a small proportion of patients derive long-term clinical benefit. Here, we describe the biomarkers associated with the complex relationship between tumour-related immune stimulus, T cell-mediated immune response, and immune modulation of the microenvironment that can help to predict improved patient outcomes. [ABSTRACT FROM AUTHOR]