Background: The systemic treatment of advanced cutaneous squamous cell carcinoma (cSCC)
has seen significant developments in recent years. The anti-PD1 inhibitor cemiplimab
has demonstrated efficacy in clinical trials, but real-world data are still limited.
Here, we aimed to evaluate the efficacy and the safety of cemiplimab in a real-world
clinical setting. Methods: A retrospective analysis was carried out for all patients
who received at least two doses of cemiplimab at our department between February 2020
and January 2023. Progression-free survival (PFS), overall survival (OS), the objective
response rate (ORR), the disease control rate (DCR) and adverse events (AEs) were
evaluated. Results: Twenty-five patients were included with a median age of 78 (65–82)
years. The median treatment duration was 48 (16–72) weeks. Five (20%) patients were
immunocompromised. Sixteen patients (64%) developed AEs, including 36% serious AEs
(SAEs) of grade ≥ 3. Six patients (24%) were withdrawn from treatment due to the occurrence
of AEs. Among the 25 patients, 52% showed an objective response (3 complete and 10
partial responses), 76% had controlled disease and 24% experienced progression. Among
the five immunocompromised patients, the ORR was 60%, while the DCR was 80%. Conclusions:
This retrospective real-world study revealed that locally advanced or metastatic cSCC
could be effectively treated with cemiplimab even in elderly, polymorbid and immunocompromised
patients.