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.
Nizar M. Tannir, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III findings from the PIVOT-09 study, which compared bempegaldesleukin plus nivolumab with the investigator’s choice of a tyrosine kinase inhibitor (either sunitinib or cabozantinib) in patients with previously untreated advanced renal cell carcinoma (Abstract LBA68).
Martin Reck, MD, PhD, of Germany’s Lung Clinic Grosshansdorf, details two trials that included patients with advanced non–small cell lung cancer: 3-year survival outcomes in the EMPOWER-Lung 1 study of continued cemiplimab-rwlc beyond disease progression with the addition of chemotherapy, and phase III results from the IFCT-1701 trial of nivolumab plus ipilimumab 6-month treatment vs treatment continuation (LBA54 and Abstract 972O).
Sapna P. Patel, MD, of The University of Texas MD Anderson Cancer Center, discusses the latest findings from the SWOG S1801 trial, which showed that using single-agent pembrolizumab as neoadjuvant therapy improved event-free survival compared to adjuvant therapy in high-risk resectable stage III–IV melanoma (Abstract LBA6).
Ana Oaknin, MD, PhD, of Barcelona’s Vall d’Hebron University Hospital, discusses findings from the CheckMate 358 trial, which showed that chemotherapy-free immunotherapy with nivolumab alone or in combination with ipilimumab may provide durable tumor regression with manageable toxicity in patients with recurrent or metastatic cervical cancer, regardless of tumor PD-L1 expression (Abstract 520MO).
Richard S. Finn, MD, of the Geffen School of Medicine at the University of California, Los Angeles, discusses primary phase III results from the LEAP-002 study of pembrolizumab, an anti–PD-1 therapy, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor, vs lenvatinib monotherapy in patients with advanced hepatocellular carcinoma (Abstract LBA34).