Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2026
Cemiplimab in cutaneous squamous cell carcinoma: a longer follow-up study focusing on the late toxicities.
СтатьяНазвание и аннотация: Перевод в очереди
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Rubatto Marco, Baggi Alice, Depenni Roberta, Guida Michele, Ascierto Paolo Antonio, Queirolo Paola, Peris Ketty, Spagnolo Francesco, Bianchi Luca, De Galitiis Federica, Zamparini Manuel, Proietti Ilaria, Marconcini Riccardo, Botticelli Andrea, Barbieri Vito, Alfieri Salvatore, Fargnoli Maria Concetta, Occelli Marcella, Fava Paolo, Capacchione Alessio, Comunanza Valentina, Bossi Paolo, Quaglino Pietro
Аннотация
BACKGROUND AND OBJECTIVES: Cemiplimab was the first systemic therapy approved for advanced cutaneous squamous cell carcinoma (cSCC).
PATIENTS AND METHODS: We report findings from the Italian early access program cohort, comprising 134 patients treated with cemiplimab, with emphasis on late-onset toxicities and long-term clinical outcomes. Late toxicities were defined as treatment-related adverse events (TRAEs) occurring ≥ 6 months after therapy initiation. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated.
RESULTS: Median PFS was 9 months. 58 (43.3%) patients experienced progression while 76 (56.7%) maintained a response. Median OS was 21 months (range 0-32), and 67 (50%) patients died. The ORR and DCR were 58.9% and 72.4%, respectively. CR increased from 15% (20 patients) in September 2020 to 19.4% (26 patients) in early 2022. 15 (11.2%) patients had at least one TRAE and 2 of them stopped cemiplimab. Median time to TRAE onset was 12 months (range 6-23); all events resolved after therapy discontinuation, and none of the AEs became chronic.
CONCLUSIONS: With a longer follow-up than that reported in registrational studies and real-world reports, the clinical activity of cemiplimab was confirmed, with a limited incidence of late toxicities. However, some TRAEs may emerge after prolonged treatment.
PATIENTS AND METHODS: We report findings from the Italian early access program cohort, comprising 134 patients treated with cemiplimab, with emphasis on late-onset toxicities and long-term clinical outcomes. Late toxicities were defined as treatment-related adverse events (TRAEs) occurring ≥ 6 months after therapy initiation. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated.
RESULTS: Median PFS was 9 months. 58 (43.3%) patients experienced progression while 76 (56.7%) maintained a response. Median OS was 21 months (range 0-32), and 67 (50%) patients died. The ORR and DCR were 58.9% and 72.4%, respectively. CR increased from 15% (20 patients) in September 2020 to 19.4% (26 patients) in early 2022. 15 (11.2%) patients had at least one TRAE and 2 of them stopped cemiplimab. Median time to TRAE onset was 12 months (range 6-23); all events resolved after therapy discontinuation, and none of the AEs became chronic.
CONCLUSIONS: With a longer follow-up than that reported in registrational studies and real-world reports, the clinical activity of cemiplimab was confirmed, with a limited incidence of late toxicities. However, some TRAEs may emerge after prolonged treatment.