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Evaluation of clinical parameters associated with response and resistance to cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma: a multi-Institutional retrospective cohort study

Haigh, J. E.
Rack, S.
Yan, R.
Babu, S.
Donnelly, O.
Walter, H.
Faust, G.
Bhagani, S.
Isola, P.
Metcalf, R.
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Abstract
Cutaneous squamous cell carcinoma (cSCC) is a common cancer with increasing incidence and 5% of patients develop incurable disease, often resistant to chemotherapy. The anti-PD-1 therapy cemiplimab has shown high efficacy in clinical trials. This retrospective study evaluated the real-world effectiveness of cemiplimab in incurable cSCC and examined factors influencing response and toxicity. Data from 86 patients across three UK healthcare providers were analysed. Median progression-free survival (PFS) and overall survival (OS) were not reached, with 38% showing durable responses beyond 12 months. The overall response rate was 60.8% (95% CI 49-71), and the clinical benefit rate was 74.3% (95% CI 63-83). A head and neck primary site was associated with improved PFS (p = 0.008) and OS (p = 0.023), while concurrent immunosuppression was associated with worse PFS (p < 0.001). These findings align with clinical trials, suggesting cemiplimab is effective and safe in the recurrent/metastatic setting.
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2025
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Haigh JE, Rack S, Yan R, Babu S, Donnelly O, Walter H, et al. Evaluation of Clinical Parameters Associated with Response and Resistance to Cemiplimab in Locally Advanced and Metastatic Cutaneous Squamous Cell Carcinoma: A Multi-Institutional Retrospective Cohort Study. Current oncology (Toronto, Ont). 2025 Mar 15;32(3). PubMed PMID: 40136372. Pubmed Central PMCID: PMC11941019. Epub 2025/03/26. eng.
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