Journal article

Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial

Michael R Migden, Nikhil I Khushalani, Anne Lynn S Chang, Karl D Lewis, Chrysalyne D Schmults, Leonel Hernandez-Aya, Friedegund Meier, Dirk Schadendorf, Alexander Guminski, Axel Hauschild, Deborah J Wong, Gregory A Daniels, Carola Berking, Vladimir Jankovic, Elizabeth Stankevich, Jocelyn Booth, Siyu Li, David M Weinreich, George D Yancopoulos, Israel Lowy Show all

The Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2020

Abstract

BACKGROUND: Cemiplimab has shown substantial antitumour activity in patients with metastatic cutaneous squamous cell carcinoma. Patients with locally advanced cutaneous squamous cell carcinoma have poor prognosis with conventional systemic therapy. We present a primary analysis of the safety and antitumour activity of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma. METHODS: This pivotal open-label, phase 2, single-arm trial was done across 25 outpatient clinics, primarily at academic medical centres, in Australia, Germany, and the USA. Eligible patients (aged ≥18 years with histologically confirmed locally advanced cutaneous squamous cell carcinoma and an East..

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Funding Acknowledgements

This study was funded by Regeneron Pharmaceuticals and Sanofi. We thank the patients, their families, all other investigators, and all investigational site members involved in this study. We also thank Q2 Solutions EA Genomics, Morrisville, NC, USA, for doing the tumour mutational burden analysis. Nikita Mehta and Robert Charnas from the study sponsors reviewed and provided editorial comments on the manuscript. Medical writing and editorial support under the direction of the authors was provided by Emmanuel Ogunnowo of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals and Sanofi according to Good Publication Practice guidelines. Responsibility for all opinions, conclusions, and data interpretation lies with the authors.