Advertisement


Neil D. Gross, MD, on Cutaneous Squamous Cell Carcinoma: Recent Findings on Cemiplimab

ESMO Congress 2022

Advertisement

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).



Transcript

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.

Related Videos

Skin Cancer

John B.A.G. Haanen, MD, PhD, on Melanoma: Phase III Data on Treatment With Tumor-Infiltrating Lymphocytes vs Ipilimumab

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).

Breast Cancer
Immunotherapy

Marleen Kok, MD, PhD, on Triple-Negative Breast Cancer: Nivolumab Monotherapy or in Combination Therapy

Marleen Kok, MD, PhD, of The Netherlands Cancer Institute in Amsterdam, discusses the initial results from the BELLINI trial, which tested whether short-term preoperative nivolumab, either as monotherapy or in combination with low-dose doxorubicin or novel immunotherapy combinations, can induce immune activation in patients with early-stage triple-negative breast cancer with tumor-infiltrating lymphocytes (Abstract LBA13).

Hepatobiliary Cancer

Richard S. Finn, MD, on Hepatocellular Carcinoma: Recent Data on Lenvatinib Plus Pembrolizumab

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).

Breast Cancer
Genomics/Genetics

Antonio Marra, MD, on Metastatic Breast Cancer: Patterns of Genomic Instability and Their Effect on 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).

Skin Cancer
Immunotherapy

Sapna P. Patel, MD, on Melanoma: New Data on Pembrolizumab, Adjuvant vs Neoadjuvant Plus Adjuvant

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).

Advertisement

Advertisement




Advertisement