Neil D. Gross, MD, on Cutaneous Squamous Cell Carcinoma: Recent Findings on Cemiplimab
ESMO Congress 2022
Neil D. Gross, MD, of The University of Texas MD Anderson Cancer Center, discusses data from a phase II study, which showed that neoadjuvant cemiplimab-rwlc in patients with stage II–IV (M0) resectable cutaneous squamous cell carcinoma is active and may enable function-preserving surgery in some cases (Abstract 789O).
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
In this confirmatory, multicenter trial, we investigated new adjuvant Cemiplimab in 79 patients with resectable stage II to IV cutaneous squamous cell carcinoma.
The impetus for this trial was a pilot study that we conducted among patients with stage III and IV disease at a single institution, MD Anderson, where we found an extraordinary pathologic complete response rate, 55% among 20 patients. The long term follow up from that study was presented at ASCO in 2022 and demonstrated three-year longterm survival. So the impetus for this trial was to confirm those results. We investigated 79 patients over 20 centers in the US, Australia, and Europe. We enrolled patients over about a year and a half timeframe during COVID.
What we found in this study was that 50.6% of patients, so 40 out of 79 patients, also had a complete pathologic response to new adjuvant therapy with four doses of Cemiplimab. Another 10 patients had a major pathologic response, so less than or equal to 10% residual viable tumor cells in the specimen, after neoadjuvant therapy. We found 20 patients that had a less complete pathologic response. And there were some patients who were not a valuable, some patients who refused surgery because of dramatic clinical responses. There were also some patients who progressed, although that was the minority.
This was a first part of the study, the initial portion. So just looking at the primary endpoint of pathologic, complete response, we do not have longterm follow up data yet, or quality of life outcomes data. These are maturing and look forward to presenting these, but the data so far presented demonstrate significant pathologic responses that we think will be durable. And because of this, we're excited about the longterm follow up.
This study was published in the New England Journal of Medicine, and we're excited that it offers an opportunity for patients, a new approach, a novel approach to treating this aggressive disease. In the future, we hope that patients may be selected for less aggressive treatments based on their response to neoadjuvant treatment. There may be patients who don't need radiation after surgery. There may be patients who don't need surgery at all. Hopefully, we'll be able to find biomarkers to help predict responses to treatment better in the future. In the current study, we collected circulating tumor DNA as part of the study, and that can be informative, we hope in the future. But at this point it's still premature to say, who will and who will not respond to this approach, that includes both tumor mutational burden and PDL1 status, both of which we investigated and was not informative in selecting patients for response to treatment.
Antonio Marra, MD, of Memorial Sloan Kettering Cancer Center, discusses a mutational signature analysis that reveals patterns of genomic instability linked to resistance to endocrine therapy with or without CDK4/6 inhibition in patients with estrogen receptor–positive/HER2-negative metastatic breast cancer (Abstract 210O).
Christelle de la Fouchardiere, MD, of France’s Centre Léon Bérard, discusses phase III findings from the PRODIGE 65–UCGI 36–GEMPAX UNICANCER study, which evaluated whether the combination of gemcitabine and paclitaxel improves overall survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma after FOLFIRINOX failure or intolerance (Abstract LBA60).
John B.A.G. Haanen, MD, PhD, of The Netherlands Cancer Institute, discusses recent phase III findings, which show that tumor-infiltrating lymphocytes (TILs) improve progression-free survival compared with ipilimumab by 50% in patients with advanced melanoma after not responding to anti–PD-1 treatment. Around 50% of TIL-treated patients had a response, and 20% had a complete response (Abstract LBA3).
Tony S.K. Mok, MD, of The Chinese University of Hong Kong, discusses two late-breaking abstracts presented at ESMO 2022: the phase II SUNRISE study, which compared sintilimab plus anlotinib vs platinum-based chemotherapy as first-line therapy in patients with metastatic non–small cell lung cancer (NSCLC); and the ORIENT-31 trial, which compared sintilimab with or without IBI305 (a bevacizumab biosimilar) plus chemotherapy in patients with EGFR-mutated nonsquamous NSCLC who experienced disease progression on EGFR tyrosine kinase inhibitors.
Jean-Pascal Machiels, MD, PhD, of Belgium’s Cliniques universitaires Saint-Luc (UCLouvain), discusses the primary results of the phase III KEYNOTE-412 study of pembrolizumab plus chemoradiation therapy (CRT) vs placebo plus CRT for patients with locally advanced head and neck squamous cell carcinoma (Abstract LBA5).