Real-world efficacy and safety of cemiplimab in Japanese patients with recurrent or metastatic cervical cancer: A single-center retrospective cohort study.

OBJECTIVE: To evaluate the real-world efficacy and safety of cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer (R/M CC), including patients from subgroups underrepresented in clinical trials. METHODS: We conducted a single-center, retrospective cohort study of 25 consecutive patients with R/M CC treated with cemiplimab between April 2023 and April 2025. Outcomes included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Responses were assessed by RECIST version 1.1, and treatment-emergent adverse events (TEAEs) were graded according to CTCAE version 5.0. RESULTS: The median follow-up was 12.6 months. The ORR was 16.0% (95% CI, 4.5-36.1%) and the DCR was 64.0% (95% CI, 42.5-82.0%). The median PFS was 2.8 months (95% CI, 2.1-3.5), and the median OS was 12.6 months (95% CI, 5.1-20.1). All patients with recurrence confined to a previously irradiated field achieved disease control. No treatment-related deaths occurred. CONCLUSIONS: Cemiplimab demonstrated manageable toxicity and clinically meaningful disease control in routine practice, including patients with biologically aggressive tumors or recurrences in previously irradiated fields.