Real-world experience with first- versus second-line cemiplimab for advanced basal cell carcinoma

DeTemple, Viola K. and Kaatz, Martin and Stockfleth, Eggert and Scheel, Christina and Angela, Yenny and Gutzmer, Ralf and Leiter, Ulrike and Meier, Friedegund and Schadendorf, Dirk and Livingstone, Elisabeth and Gebhardt, Christoffer and von Wasielewsk, Imke and Weichentha, Michael and Mohr, Peter and Hassel, Jessica and Pfoehler, Claudia and Simon, Jan Christoph and Jochims, Franziska and Terheyden, Patrick and Ulrich, Jens and Haferkamp, Sebastian and Drexler, Konstantin and Schilling, Bastian and Glutsch, Valerie and Heinzerling, Lucie and Berking, Carola and Ugurel, Selma and Tomsitzw, Dirk (2025) Real-world experience with first- versus second-line cemiplimab for advanced basal cell carcinoma. EUROPEAN JOURNAL OF CANCER, 225: 115590. ISSN 0959-8049, 1879-0852

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Abstract

Background: The anti-PD1 antibody (PD1i) cemiplimab is approved as second-line treatment for locally advanced or metastatic basal cell carcinoma (BCC), resulting in an ORR of 20-30 %. This study aimed to investigate the efficacy of cemiplimab as first-line or second-line treatment of BCC in a German real-world patient cohort. Methods: Patients with histologically confirmed locally advanced or metastatic BCC who were treated with cemiplimab were retrospectively identified from the prospective multicenter real-world skin cancer registry ADOREG. Study endpoints were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Therapy outcome was compared between patients receiving first-line cemiplimab and patients treated with cemiplimab in second-line. Results: 37 patients from 17 skin cancer centers were identified who received cemiplimab. The median follow-up after start of any first-line treatment was 37.1 months, and 17.9 months after initiation of any cemiplimab treatment. Patients who received first-line cemiplimab (n symbolscript 8) had an ORR of 62.5 %, compared to an ORR of 31.0 % for patients who received second-line cemiplimab (n symbolscript 29); Median PFS was 19.8 months for first-line cemiplimab and 5.3 months for second-line cemiplimab. Reinduction with HHIs after progression on second-line cemiplimab resulted in an ORR of 20.0 % and a median PFS of 3.8 months. Conclusion: We demonstrate a comparable outcome for cemiplimab as second-line treatment of BCC in our real-world patient cohort as reported in previous registration studies. Additionally, we found a trend for a more favorable outcome in first-line therapy, suggesting a rationale to further investigate cemiplimab as first-line treatment of advanced BCC.

Item Type: Article
Uncontrolled Keywords: EXPRESSION; Basal cell carcinoma; Immune checkpoint inhibitor; Real world data; Cemiplimab; Hedgehog inhibitor
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Dermatologie und Venerologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 27 Mar 2026 08:22
Last Modified: 27 Mar 2026 08:22
URI: https://pred.uni-regensburg.de/id/eprint/67938

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