Fifty-one percent of patients receiving neoadjuvant therapy with cemiplimab for resectable stage II, III, or IV (M0) cutaneous squamous cell carcinoma had a pathological complete response, according to a study published online Sept. 12 in the New England Journal of Medicine to coincide with the annual meeting of the European Society for Medical Oncology, held from Sept. 9 to 13 in Paris.

Neil D. Gross, M.D., from the M.D. Anderson Cancer Center in Houston, and colleagues conducted a phase 2 multicenter, nonrandomized study to examine cemiplimab as neoadjuvant therapy prior to surgery with curative intent in patients with resectable stage II, III, or IV (M0) cutaneous squamous cell carcinoma.

The researchers found that on independent review, 40 patients (51 percent) had a pathological complete response and 10 patients (13 percent) had a pathological major response. These results were consistent with the investigator assessment-determined pathological responses. In 54 patients (68 percent), an objective response was observed on imaging. Sixty-nine patients (87 percent) had adverse events of any grade, regardless of whether they were attributed to study treatment. During the study period, 14 patients (18 percent) had grade 3 or higher adverse events.

"The potential for function-preserving surgery, together with the high frequency of a pathological complete response, supports the use of neoadjuvant therapy with cemiplimab in this patient population," the authors write.

The study was funded by Regeneron and Sanofi, the manufacturers of cemiplimab.

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