CemiplimAb-rwlc Survivorship and Epidemiology (CASE): A Prospective, Non-Interventional Study of the Safety and Effectiveness of Cemiplimab in Immunocompromised/Immunosuppressed Patients With Advanced Cutaneous Squamous Cell Carcinoma at 2 Years’ Follow-Up
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Keywords
Cemiplimab, advanced cutaneous squamous cell carcinoma, immunocompromised/immunosuppressed patients, safety, efficacy, real-world study
Abstract
Introduction: Cemiplimab is a programmed cell death-1 (PD-1) inhibitor approved in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation. Despite high prevalence of CSCC, immunocompromised or immunosuppressed (IC/IS) patients have been excluded from registration studies due to potentially reduced treatment efficacy. Here, we present the safety and effectiveness of cemiplimab in IC/IS patients with advanced CSCC from a non-interventional study in the real-world setting, at 2 years’ follow-up.
Methods: CASE is a phase 4, multicenter, prospective, non-interventional study evaluating the effectiveness and safety of cemiplimab in patients with advanced CSCC (NCT03836105). Data were collected from 65 United States academic and community oncology centers.
Results: As of 24 March 2025, 254 patients with advanced CSCC had received ≥1 dose of intravenous cemiplimab 350 mg every 3 weeks. Of these, 42 (16.5%) patients were IC/IS. Most IC/IS patients were white (90.5%), male (76.2%), ≥65 years of age (88.1%), and had locally advanced disease (57.1%). The IC/IS patients were divided into 3 categories: with hematologic malignancies (45% - chronic lymphocytic leukemia, myeloproliferative disorders, or other leukemia), immunosuppressed (33% - immune disorders or human immunodeficiency virus infection), and organ transplant recipients (22% - kidney, liver, or pancreas). Median duration of exposure was 43.9 weeks. Objective response rate was achieved in 45.2% of patients, with 23.8% having a complete response. Median progression-free survival was similar in IC/IS vs non-IC/IS patients, at 14.6 and 15.7 months, respectively. Treatment-related immune-related adverse events occurred in 31.0% of patients and treatment-related serious adverse events occurred in 7.1% of patients. The proportion of IC/IS patients experiencing adverse events was similar to that of the non-IC/IS population. Among the 9 transplant patients, 7 had stable transplant status and 2 had rejection episodes leading to treatment-related allograft loss.
Conclusion: This analysis suggests that the safety and efficacy of cemiplimab in IC/IS patients with advanced CSCC are similar to those observed in non-IC/IS patients in this real-world study.
Funding: Regeneron Pharmaceuticals, Inc.
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