Perioperative Use of Cemiplimab Under Study in Cutaneous Squamous Cell Carcinoma
Posted: Friday, July 16, 2021
Michael C. Lowe, MD, MA, of Emory University, Atlanta, and colleagues proposed a single-arm pilot study to determine whether treatment with the PD-1 inhibitor cemiplimab may improve surgical outcomes and reduce long-term recurrence rates in patients with high-risk resectable cutaneous squamous cell carcinoma if used in the perioperative setting. The Winship 4851-19 trial protocol was presented in poster format during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS9593).
“Cemiplimab was approved in 2018 for treatment of locally advanced or metastatic cutaneous squamous cell carcinoma that is not curable with surgery or radiation [therapy],” the investigators commented. “However, patients with high-risk cutaneous squamous cell carcinoma who are able to undergo curative intent surgery are not candidates for checkpoint inhibitor therapy but still experience high rates of recurrence and/or systemic [disease] progression even when offered adjuvant radiotherapy.”
Patients with surgically resectable, histologically proven high-risk cutaneous squamous cell carcinoma will be enrolled in the pilot study. An Eastern Cooperative Oncology Group performance status score of 0 or 1 will be required; those who received prior immunotherapy will be excluded. To date, 5 of 20 patients have been enrolled; the investigators determined this sample size based on the feasibility and ability to enroll within a timely fashion.
In the neoadjuvant phase, patients will be administered three doses of cemiplimab every 3 weeks prior to undergoing standard-of-care surgery. Radiation therapy may be offered at the discretion of the investigator. In the adjuvant phase, patients will be administered cemiplimab every 3 weeks. The investigators selected pathologic response rate as the primary endpoint. The local and distant recurrence and overall survival rates will be assessed as secondary endpoints. Additionally, the investigators plan to evaluate the immune profile of fresh tumor and blood to determine the impact of neoadjuvant cemiplimab on the tumor microenvironment and circulating immune responses.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
