Neoadjuvant cemiplimab shows favourable event-free, disease-free and overall survival rates in patients with resectable CSCC
Dr Neil Gross - MD Anderson Cancer Center, Houston, USA
We’re delighted to present today the survival results, one-year follow-up survival results, from a non-randomised phase II multicentre trial of 79 patients with resectable stage 2-4 cutaneous squamous cell carcinoma. In that trial patients received up to four doses of neoadjuvant cemiplimab before curative intent surgery. Importantly in this trial, in the adjuvant setting patients were eligible to receive adjuvant cemiplimab for up to 48 weeks or adjuvant radiation or observation at the discretion of the investigator based on local pathologic review.
What we reported last year at ESMO was the primary endpoint of the study which was pathologic complete response of which we found 51% of patients achieved this mark. Another 13% had a major pathologic response. So today we’re presenting the follow-up survival results from that trial which includes event free survival, disease free survival and overall survival as well as post-hoc analysis of patients with the partial pathologic response by independent central pathologic review.
What we observed in this trial was exceptional event free survival for patients with the pathologic response. Overall, for the 79 patients included, 12-month estimated event free survival was 89% and patients who had a pathologic complete response had 95% 12-month survival. In fact, estimated event free survival was exceptional for patients with any degree of pathologic response relative to patients with either no surgery or non-response.
What would the clinical impact be of these results?
We observed exceptional survival results associated with pathologic responses to neoadjuvant cemiplimab for resectable cutaneous squamous cell carcinoma. Of the patients who had a pathologic complete response, 40 patients, none have recurred despite the fact that only one of these patients received adjuvant radiation. These results have prompted the development of a randomised registrational intent phase III trial which is scheduled to open in 2024.
