Phase II Study of Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous Cell Carcinoma: Final Analysis
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: We previously reported the results of a multicenter phase II trial (ClinicalTrials.gov identifier: NCT04154943) of neoadjuvant cemiplimab in resectable stage II to IV cutaneous squamous cell carcinoma (CSCC), in which the pathologic complete response (pCR) rate was 51%. At the 19-month follow-up, estimated 12-month event-free survival (EFS) was 89%, with 11 EFS events. In this study, we report final EFS and overall survival (OS) at a median follow-up of 54 months. Overall, 16 EFS events occurred at final analysis. There were no new disease recurrence events. The five new EFS events were all comorbidity-related deaths without CSCC recurrence. Overall estimated 54-month EFS was 76.2% (81.5% in patients with pCR, 88.9% in patients with major pathologic response, 100% in patients with partial pathologic response, and 45.7% in nonresponders/not-evaluable patients). Among 40 patients with pCR, none had experienced disease recurrence. Overall estimated 54-month OS was 79.4%. No new grade ≥3 treatment-emergent adverse events occurred. The final analysis demonstrates durable EFS and OS, no late recurrences, and no new safety signals with neoadjuvant cemiplimab.
Source: Journal of Clinical Oncology
DOI: 10.1200/jco-26-02166
Authors: Neil D. Gross, David M. Miller, Nikhil I. Khushalani, Vasu Divi, Emily S. Ruiz, Evan J. Lipson, Friedegund Meier, Yungpo Bernard Su, Paul L. Swiecicki, Jennifer Atlas, Jessica L. Geiger, Axel Hauschild, Jennifer Hsing Choe, Brett G.M. Hughes, Annette M. Lim, Renata Ferrarotto, Bei Wang, Weiwei Tao, Laura Brennan, Suk-Young Yoo, Frank Seebach, Israel Lowy, Melissa Mathias, Hyunsil Han, Matthew G. Fury, Danny Rischin
Institutions: The University of Texas MD Anderson Cancer Center, Harvard University, Mass General Brigham, Moffitt Cancer Center, Stanford Medicine, Stanford University, Brigham and Women's Hospital, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, National Center for Tumor Diseases, Nationales Centrum für Tumorerkrankungen Dresden, Technische Universität Dresden, Nebraska Cancer Specialists, University of Michigan, Cleveland Clinic, University Hospital Schleswig-Holstein, Duke University, Duke Cancer Institute, The University of Queensland, Royal Brisbane and Women's Hospital, The University of Melbourne, Peter MacCallum Cancer Centre, Regeneron (United States)
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7223456142