Christian U. Blank, MD, PhD
Christian U. Blank, MD, PhD, Professor of Internal Medicine, staff member at Netherlands Cancer Institute, Professor at the University of Regensburg in Germany, and founding member of the International Neoadjuvant Melanoma Consortium, was the invited discussant of the MD Anderson study of cemiplimab-rwlc in resectable cutaneous squamous cell carcinoma.1
“This was a single-arm trial, and the data are early—we only have response data—but the pathologic complete response rate of 51% is very promising,” Dr. Blank said. The high 63% rate of pathologic responses (complete and major) was underestimated by the radiologic response, which has been seen in other trials, he said. “We still need to find a biomarker with which we could judge our neoadjuvant therapies without the invasive resection of the tumor.”
There was some suggestion that tumor mutational burden and PD-L1 expression might be slightly correlated. However, Dr. Blank acknowledged, PD-L1 is “not a good discriminator” because some patients with PD-L1–negative disease also responded. The interferon signature was not part of the evaluation but could potentially be useful if combined with tumor mutational burden and PD-L1 expression, he added.
The 18% rate of grade 3 or 4 toxicities is “in the expected range,” he noted, though it is somewhat higher than that with neoadjuvant pembrolizumab in the SWOG S1801 trial of melanoma, also presented at the European Society for Medical Oncology (ESMO) Congress 2022.2
“We want to see the maturation of the data. Are these durable responses? Is the pathologic response rate a surrogate for event-free survival? And can we achieve the same results with two doses of cemiplimab rather than four?” he questioned.
“I hope we will see a randomized trial as soon as possible to establish this approach. With cutaneous squamous cell carcinoma—a very common disease—I think this should be easily implementable,” he concluded.
DISCLOSURE: Dr. Blank reported financial relationships with Bristol Myers Squibb, MSD, Roche, Novartis, GlaxoSmithKline, AstraZeneca, Pfizer, Lilly, GenMab, Pierre Fabre, Third Rock Ventures, Immagene BV, and Signature Oncology. He also has a patent pending (WO 2021/177822 A1).
1. Gross ND, Miller DM, Khushalani N, et al: Neoadjuvant cemiplimab in patients with stage II–IV (M0) cutaneous squamous cell carcinoma: Primary analysis of a phase II study. ESMO Congress 2022. Abstract 789O. Presented September 12, 2022.
2. Patel S, Othus M, Prieto V, et al: Neoadjuvant versus adjuvant pembrolizumab for resected stage III-IV melanoma (SWOG S1801). ESMO Congress 2022. Abstract LBA6. Presented September 11, 2022.
In an international, multicenter phase II clinical trial, almost two-thirds of patients with stage II to IV cutaneous squamous cell carcinoma had tumors nearly or completely eradicated by neoadjuvant treatment with cemiplimab-rwlc, an agent targeting PD-1. The results were presented at the European ...