New Findings Support Use of Cemiplimab as Neoadjuvant Therapy in Patients with Resectable Cutaneous Squamous Cell Carcinoma

by Linda Kossoff •

How effective is neoadjuvant therapy with cemiplimab (up to four doses) for resectable stage II, III, or IV cutaneous squamous cell carcinoma (SCC)?

BOTTOM LINE

Neoadjuvant therapy with cemiplimab was associated with a pathological complete response in a high percentage of patients with resectable cutaneous SCC.

COMMENT: This study is interesting, as neoadjuvant immunotherapy is emerging as an effective and exciting treatment option for cutaneous squamous cell carcinoma. —Brian Cervenka, MD

BACKGROUND: Surgery successfully treats most patients with early stage cutaneous SCC. Those with loco-regionally advanced disease/disease with adverse histopathological features can be treated with adjuvant radiation therapy and possibly systemic therapy. Cemiplimab is approved to treat metastatic or locally advanced cutaneous SCC for which no curative local treatments are available.

STUDY DESIGN: Confirmatory, multicenter, nonrandomized study.

SETTING: Department of Head and Neck Surgery and the Department of Thoracic and Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, Texas.

SYNOPSIS: In this study, 79 adult patients with resectable stage II, III, or IV (M0) cutaneous SCC received cemiplimab at a dose of 350 mg every three weeks for up to four doses before undergoing surgery. Seventy-four patients had stage III or IV disease, and the primary tumor site for 91% of patients was head and neck. The primary end point was a pathological complete response (absence of viable tumor cells in the surgical specimen). Key secondary end points included a pathological major response (presence of viable tumor cell constituting < 10% of the surgical specimen). All patients underwent imaging assessments at week six (before dose three) and week 12 (before surgery). During the neoadjuvant period, 62 patients received all four doses of cemiplimab. A pathological complete response was observed in 40 patients and a pathological major response in 10 patients. Grade 3 or higher adverse events that occurred during the study period were observed in 14 patients. Twenty patients had no pathological complete or major response, with viable tumor cells > 10% of the surgical specimen. Study limitations included the absence of a control group.

CITATION: Gross ND, Miller, DM, Khushalani NI, et al. Neoadjuvant cemiplimab for stage II to IV cutaneous squamous cell carcinoma. N Engl J Med. 2022;387:1557–1568.