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DeTemple, Viola K. ORCID logoORCID: https://orcid.org/0000-0001-6246-8862; Kaatz, Martin ORCID logoORCID: https://orcid.org/0000-0002-0650-2576; Stockfleth, Eggert; Scheel, Christina; Angela, Yenny ORCID logoORCID: https://orcid.org/0000-0002-6643-7286; Gutzmer, Ralf ORCID logoORCID: https://orcid.org/0000-0001-7921-2820; Leiter, Ulrike; Meier, Friedegund ORCID logoORCID: https://orcid.org/0000-0003-4340-9706; Schadendorf, Dirk ORCID logoORCID: https://orcid.org/0000-0003-3524-7858; Livingstone, Elisabeth ORCID logoORCID: https://orcid.org/0000-0001-8279-9239; Gebhardt, Christoffer ORCID logoORCID: https://orcid.org/0000-0001-7090-9584; Wasielewski, Imke von; Weichenthal, Michael ORCID logoORCID: https://orcid.org/0000-0002-9060-4961; Mohr, Peter; Hassel, Jessica ORCID logoORCID: https://orcid.org/0000-0001-7575-6230; Pföhler, Claudia ORCID logoORCID: https://orcid.org/0000-0003-0384-114X; Simon, Jan Christoph; Jochims, Franziska ORCID logoORCID: https://orcid.org/0000-0003-2279-2072; Terheyden, Patrick; Ulrich, Jens; Haferkamp, Sebastian; Drexler, Konstantin; Schilling, Bastian; Glutsch, Valerie ORCID logoORCID: https://orcid.org/0000-0001-9291-1327; Heinzerling, Lucie ORCID logoORCID: https://orcid.org/0000-0001-5718-3643; Berking, Carola; Ugurel, Selma ORCID logoORCID: https://orcid.org/0000-0002-9384-6704 und Tomsitz, Dirk ORCID logoORCID: https://orcid.org/0000-0003-0036-072X (2025): Real-world experience with first- versus second-line cemiplimab for advanced basal cell carcinoma. In: European Journal of Cancer, Bd. 225, 115590 [PDF, 2MB]

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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 = 8) had an ORR of 62.5 %, compared to an ORR of 31.0 % for patients who received second-line cemiplimab (n = 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.

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