Dr Gross on the Background of Investigating Neoadjuvant Cemiplimab in CSCC

Neil D. Gross, MD, FACS, surgeon-scientist, director, Clinical Research, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, discusses the rationale for launching a phase 2 study (NCT04154943) evaluating neoadjuvant cemiplimab (Libtayo) in patients with cutaneous squamous cell carcinoma (CSCC), highlighting 1-year follow-up data derived from the study.

At the 2023 ESMO Congress, EFS data were presented for the entire patient cohort and stratified by pCR as determined by independent central pathologic review. These findings were simultaneously published in Lancet Oncology, Gross says.

As of the December 1, 2022, cutoff date, the median follow-up was 18.7 months, he continues. Gross shared that data from the nonrandomized, multicenter study revealed that the estimated 12-month event-free survival (EFS) rate with cemiplimab was 89.0% (95% CI, 79.1%-94.3%) in the entire population (n = 79). Among patients who achieved a pathologic complete response (pCR; n = 40), the estimated 12-month EFS rate was notably higher at 94.9% (95% CI, 81.0%-98.7%). Notably, patients showing pathologic response exhibited more favorable EFS rates compared with those who underwent no surgery or showed no response, Gross concludes.

The phase 2 trial enrolled patients with resectable CSCC ranging from stages II to IV, Gross begins. Of note, the trial's primary end point was pCR, reflecting the remarkable responses observed with cemiplimab in preliminary data, he adds. During the trial, the decision regarding adjuvant treatment was left to the discretion of the investigators due to the perceived impracticality of specifying it beforehand, Gross says. Consequently, investigators could opt for patients to receive adjuvant cemiplimab for up to 48 weeks, adjuvant radiation, or observation, he emphasizes. The patient population in this trial represented the typical demographic profile of patients with advanced CSCC, which predominantly affects White males and older individuals, Gross expands, noting that the trial included a patient as old as 93 years, which is not an unusual age for patients with this disease.