Immunotherapy before surgery helpful for common skin cancer patients: Study

In an international, multicenter Phase II clinical trial led by The University of Texas MD Anderson Cancer Center, 63.3% of patients with stage II–IV cutaneous squamous cell carcinoma (CSCC) saw their tumors nearly or completely disappear when treated with immunotherapy before surgery.

About 1 million people in the U.S. are diagnosed with CSCC each year, making it one of the most common forms of cancer. Most cases are easily treated by a dermatologist or primary care physician and do not require advanced care. However, most CSCCs occur in the head and neck regions – areas that receive heavy sun exposure – and, in the rare instances that they do grow and spread aggressively, they can affect the eyes, ears, nose and mouth.

The current standard of care, involving surgical excision and radiation, can be disfiguring and result in loss of important functions. Although not an endpoint of the study, the response to neoadjuvant (pre-surgical) immunotherapy enabled less invasive, function-preserving surgery in some cases.

In 2018, the Food and Drug Administration (FDA) approved cemiplimab for patients with metastatic CSCC who are not candidates for curative surgery or radiation.

The single-arm study enrolled 79 patients in the U.S., Australia and Europe with operable stage II–IV CSCC to receive four doses of neoadjuvant cemiplimab followed by curative-intent surgery, with optional adjuvant radiation therapy. Patients had scans before surgery, but the imaging responses (6.3% complete response) underestimated pCR (50.6%). The overall response rate from imaging was 68.4%, with most responses classified as partial responses.