![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
Abstract
Background
Prior to the Food and Drug Administration approval of cemiplimab in 2018, the median overall survival (OS) for adult patients with advanced CSCC receiving systemic therapy was approximately 8 to 15 months. Limited real-world data are available on cemiplimab for this indication in the US.
Patients and Methods
This retrospective cohort study included US patients with advanced CSCC initiating cemiplimab monotherapy in a real-world database (2018–2021). A clinical trial–like sub-cohort was identified using select criteria. Time to treatment discontinuation (TTD), time to next treatment (TTNT), and OS were estimated using Kaplan–Meier methods. Cox proportional hazard models were used to examine prognostic factors associated with OS in the main cohort.
Results
The main cohort included 622 patients (n = 240 in the trial-like cohort). In the main cohort, the median age was 78 years, 77.8% were male, 21.4% were immunocompromised/immunosuppressed, and 63.8% had metastatic CSCC. Median (95% CI) TTD and TTNT were 8.0 (6.6–9.0) months and 16.4 (13.3–21.0) months, respectively, in the main cohort. Median (95% CI) OS was 24.8 (21.8–29.1) months in the main cohort (not reached in the trial-like cohort). In multivariable analyses, age <60 years (hazard ratio [HR], 0.37), Eastern Cooperative Oncology Group performance status <3–4 (HR range, 0.13–0.57), and primary CSCC location in the head and neck only versus extremities only (HR, 0.59) were associated with better OS. Similar OS was observed between patients who had immunosuppressing/immunocompromising conditions and those without.
Conclusion
These findings confirm the effectiveness of cemiplimab among a heterogenous, real-world advanced CSCC patient population and substantiate the efficacy of cemiplimab observed in clinical trials.
Data Sharing Statement
The data that support the findings of this study have been originated by Flatiron Health, Inc. Requests for data sharing by license or by permission for the specific purpose of replicating results in this manuscript can be submitted to [email protected].
Ethics Approval
Institutional review board approval of the study protocol for creating this research database was obtained by Flatiron Health before the study was conducted and included a waiver of informed consent.
Acknowledgments
Writing assistance was provided by Catherine Mirvis (OPEN Health, Parsippany, NJ) and funded by the study sponsor.
The abstract of this paper was presented at the 2023 European Association of Dermatology (EADO) Congress and 2023 Fall Clinical Dermatology Congress as a poster presentation with interim findings. The poster’s abstract was published in the EADO Book of Abstracts (https://eado2023.com/call-for-abstracts/book-of-abstracts/) and in SKIN The Journal of Cutaneous Medicine: https://jofskin.org/index.php/skin/article/view/2549.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
Wenzhen Ge, Ning Wu, Chieh-I Chen, Timothy J Inocencio, Frank Seebach, and Matthew Fury are employees of Regeneron Pharmaceuticals, Inc. and are Regeneron Pharmaceuticals, Inc. stockholders. Patrick R. LaFontaine is an employee of Sanofi and is a Sanofi stockholder. James Harnett is an employee of Regeneron Pharmaceuticals, Inc. and is a Regeneron Pharmaceuticals, Inc. and Pfizer stockholder. Emily Ruiz has received advisory board and consulting fees from Feldan Therapeutics, Regeneron Pharmaceuticals, Inc., Merck & Co, and Checkpoint Therapeutics. She also reports grants for co-investigation from Regeneron Pharmaceuticals, Inc., Merck, and Castle Biosciences, outside the submitted work. The authors report no other conflicts of interest in this work.