The use of cemiplimab in a single regional tertiary centre to manage advanced cutaneous SCC not amenable to surgery

SDCC 

Purpose
The recently licensed immunotherapy drug cemiplimab is used to treat metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) that cannot be treated with surgery or radiotherapy. We report the experience with cemiplimab in a single tertiary centre.

Methods & Materials
Patient demographics, histology and clinical data were retrospectively collected for patients receiving cemiplimab for metastatic or locally advanced cSCC between November 2018 and March 2023. Primary objective was overall response rate (ORR). Secondary objectives included progression-free survival (PFS), overall survival (OS), and adverse events (AEs). AEs were reported according to the Common Terminology Criteria for Adverse Events, Version 4.0, as outlined by the National Cancer Institute (1).

Results
Our cohort was composed of 31 individuals: 27 male and 4 female. The median age was 78 (inter-quartile range: 10.5, range: 87). 26 patients had surgery as the primary treatment before developing metastatic/locally advanced cSCC and going on to receive cemiplimab. 20 of these 26 also received adjuvant radiotherapy at time of surgery. 3 patients had radiotherapy as the primary treatment and 2 patients had cemiplimab as the primary treatment.
20 (64.5%) patients achieved complete response, 6 (19.4%) patients achieved partial response, 2 (6.5%) patients experienced disease progression, 3 (9.7%) patients died before response assessment. ORR was 83.9% (95%CI 66.3-94.6%). Median PFS and OS were not reached after median follow-up of 13 months. 2-year PFS was 64.0% (95%CI 41.6-86.4%). 2-year OS was 73.5% (95%CI 54.2-92.8%).
24 (77.4%) patients reported AEs. Treatment was ceased in 10 (32.3%). AEs were grade 1 or 2, except myocarditis (grade 3). At data cut off, 4 (12.9%) patients had completed 2 years of treatment.

Conclusions
Our 83.9% (95%CI 66.3-94.6%) ORR exceeds the 46.1% (95%CI 38.9-53.4%) ORR of EMPOWER-CSCC 1, and our 2-year OS (73.5%) is comparable (73.3%) (2). Our findings in our cohort of 31 patients, in the context of the trial with 59 participants which gained global approval for cemiplimab, adds substantial data to the growing body of evidence on cemiplimab's long-term efficacy and supports cemiplimab as an option for patients with advanced cSCC not amenable to surgery or radiotherapy. Additionally, many patients achieved complete response with partial courses. Future studies are necessary to optimise dose and duration of cemiplimab treatment.

References
1. US Department of Health and Human Services NCI. Common Toxicity Criteria for Adverse Events, Version 4.0. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf2010.
2. Migden, Michael R., Danny Rischin, Chrysalyne D. Schmults, Alexander Guminski, Axel Hauschild, Karl D. Lewis, Christine H. Chung, et al. "PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma." New England Journal of Medicine (NEJM) 379, no. 4 (July 26, 2018): 341–51. https://doi.org/10.1056/NEJMoa1805131.

Craniomaxillofacial/Head and Neck

PSTM 2024