Neil D. Gross, MD, FACS, is head and neck surgeon and director of clinical research in the Department of Head and Neck Surgery at MD Anderson.
At this year’s European Society for Medical Oncology annual meeting, study results were presented on the use of neoadjuvant cemiplimab in the setting of stage II to IV resectable cutaneous squamous cell carcinoma (cSCC). Lead investigator Neil D. Gross, MD, FACS, head and neck surgeon and director of clinical research in the Department of Head and Neck Surgery at MD Anderson, recently discussed these results with The American Journal of Managed Care®.
Can you discuss your study presented at ESMO on cemiplimab and why the monoclonal antibody is important in making progress against cSCC?
I’m pleased to discuss our trial on neoadjuvant immunotherapy in stage II to IV cutaneous squamous cell carcinoma. It’s important to highlight up front that this is in resectable disease. Immunotherapy is approved for use in unresectable, or metastatic, cutaneous squamous cell carcinoma, but this is the first trial, other than a pilot trial we completed, to test immunotherapy in the neoadjuvant setting in resectable cutaneous squamous cell carcinoma.
The pilot study was performed here at MD Anderson; it included only 20 patients with resectable but advanced-stage disease, where the intent was really not to influence treatment. In that study, patients had to undergo the full extent of surgery after neoadjuvant therapy as they would have at baseline. We were really astounded to see the responses to treatment in that pilot trial. Over half of the patients had a complete pathologic response to treatment, and based on the strength of those results, it prompted a multicenter confirmatory trial that was reported at ESMO and published in The New England Journal of Medicine.
That confirmatory trial was completed at over 20 centers in the United States, Australia, and Europe. It enrolled 79 patients; it included patients with stage II to stage IV resectable cutaneous squamous cell carcinoma. One important difference with this study, from the pilot trial, is that it allowed for smaller surgery as patients responded to immunotherapy.
Patients in this study were allowed to have less-invasive surgery if it was oncologically appropriate. Surgeons were still required, and encouraged, to remove all gross tumor, but if they felt safe, they could preserve functionally important structures. We had several patients in the trial where that was the case. We highlighted 2 patients in the manuscript who were recommended for up-front orbital exenteration as part of their surgery and planned adjuvant radiation. In both cases, they had a partial response on imaging, but a complete pathologic response at the time of surgery, sparing the eye, and then have gone on to follow up. So very, very encouraging results.
And in the multicenter trial, we confirmed what we saw in the pilot trial, which is that over half of the patients had a complete pathologic response—no residual viable tumor—when it came time for surgery, and another 10 patients out of 79 had a near complete pathologic response. So less than 10% residual viable tumor cells in the specimens. So very, very encouraging early results from this trial.