Medical science takes a giant leap with a process that sees tumors disappearing or significantly shrinking in 63.3 percent of cutaneous squamous cell carcinoma (CSCC) patients.
According to a recent article in Inside Precision Medicine, approximately one million individuals in the United States are diagnosed with CSCC every year.
About The First Clinical Trial
Texas University’s MD Anderson led the first Phase II clinical trial. The trial results were published in the NEJM.
Participants were classified between stage II and stage IV CSCC. The process involves the malignant growth of tissue being subjected to immunotherapy prior to its being surgically removed. The new method proved highly successful and was followed by a larger, multi-center study (NCT04154943) to confirm the efficacy of the drug cemiplimab.
The FDA approved cemiplimab in 2018 in the treatment of patients who were diagnosed with CSCC but were not potential candidates for radiation or surgery.
Cemiplimab was investigated at MD Anderson in a small (n20) phase II study. Cemiplimab, a checkpoint inhibitor, focuses on PD-1 which is a protein found on some cancer cells. Several cancers are now being treated with immune checkpoint inhibitors.
The results, a seventy-five percent pathologic response rate, were presented at the 2019 ESMO Congress. Clinical Cancer Research published the findings in 2021. Pathologic response refers to therapy that is administered prior to surgery. The malignant tissue is removed and scrutinized by, as the name implies, a pathologist.
Dr. Neil Gross, the lead author of the MD Anderson study, sees these findings as the beginning of a practice change in the way resectable (surgically removable) CSCC is treated. Dr. Gross further stated that the results of the study confirm the most impressive response thus far to anti-PD1 monotherapy in solid cancer. The primary endpoints were well tolerated with a pathologic complete response rate of 50.6.
The average CSCC case is treated either by a PCP or dermatologist. However, in some rare cases, cancer can cause deformities by spreading to the ears, eyes, mouth, and nose. Although not considered an endpoint of the recent study, pre-surgical immunotherapy provided a route to several less invasive surgeries.
Seventy-nine participants living in the United States, Europe, and Australia were enrolled in the second and larger clinical study. Each person received four doses of cemiplimab followed by surgery. Radiation therapy post-surgery was optional.
Seventy patients had surgery while sixty-two patients received four doses each day of cemiplimab.
The imaging response rate was a very positive 68.4%. Dr. Gross concluded by saying that he thinks the findings will have a huge impact on quality of life. A patient can avoid radiation and require less invasive surgery. Most of all facial deformities can be avoided.
