Neoadjuvant Cemiplimab for Resectable Locoregionally Advanced Cutaneous Squamous Cell Carcinoma: A Case Series

Monday, October 13, 2025

2:54 PM - 3:00 PM EDT

Location: 127

Disclosure(s):

Whitney Jin, BA:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Sindhura Sridhar, BS:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Sarah L. Rohde, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Michael C. Topf, MD, MSCI:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Introduction: A 2022 Phase II clinical trial demonstrated that neoadjuvant cemiplumab, a PD-1 inhibitor, was associated with pathologic complete response in 50% of patients and at least a partial response in nearly 70% of patients with resectable locoregionally advanced cutaneous squamous cell carcinoma (cuSCC).

Methods: A single-institutional retrospective review of 29 patients with cuSCC of the head and neck who received at least one dose of neoadjuvant cemiplimab prior to planned definitive surgical resection between 2019-2024 was performed. Pathologic and imaging response was assessed using RECIST 1.1 criteria. Descriptive statistics were used to characterize the patient population.

Results: We identified 29 patients at our institution who had cuSCC and received at least one dose of neoadjuvant cemiplimab followed by planned surgical resection. The mean age was 71 (range 50-92) at time of diagnosis. The majority of patients were Caucasian (86.2%) males (86.2%) and had an ECOG scores of 0 or 1 (96.6%). The median number of infusions prior to surgery was 4 (range 2-28). Sixteen (55.2%) patients developed a toxicity, with the most common being fatigue and rash. Only one patient developed severe toxicity which led to cemiplimab cessation. Fifteen (52.7%) patients underwent definitive surgical resection. Among the 15 patients who underwent surgery, 9 patients (60%) had pathologic complete responses. The most cited reason for refusal of surgery was patient concerns with surgical morbidity. Fifteen patients demonstrated favorable subjective responses on gross physical examination and 6 patients had radiographic responses.

Conclusions: Neoadjuvant cemiplimab can induce a variable gross, imaging, and pathologic response depending on patient and tumors characteristics. The ongoing NRG-HN014 trial will determine whether neoadjuvant cemiplimab can improve survival.

Presenting Author(s)

Whitney Jin, BA

Medical Student
Baylor College of Medicine
Houston, TX, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Co-Author(s)

Austin T. Hoke, MD

Resident
Vanderbilt University Medical Center- Department of Otolaryngology
Nashville, TN, United States

Disclosure information not submitted.
Sindhura Sridhar, BS

Medical Student
Texas A&M School of Medicine
Austin, TX, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.
Robert J. Sinard, MD

Professor of Otolaryngology - Head and Neck Surgery
Vanderbilt University Medical Center
Nashville, TN, United States

Disclosure information not submitted.
Kyle Mannion, MD

Associate Professor
Vanderbilt University Medical Center
nashville, TN, United States

Disclosure information not submitted.
Sarah L. Rohde, MD

Associate Professor
Vanderbilt University Medical Center
Nashville, TN, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.
Alexander Langerman, MD

Professor and Bon Vivant
Vanderbilt University Medical Center
Nashville, TN, United States

Disclosure information not submitted.
Melanie D. Hicks, MD

Assistant Professor
Vanderbilt University Medical Center
Nashville, Tennessee, United States

Disclosure information not submitted.
Eben L. Rosenthal, MD

Professor and Chair
Vanderbilt University Medical Center- Department of Otolaryngology
Nashville, TN, United States

Disclosure information not submitted.

Senior Author(s)

MT

Michael C. Topf, MD, MSCI

Associate Professor of Otolaryngology - Head and Neck Surgery
Vanderbilt University Medical Center- Department of Otolaryngology
Nashville, TN, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.