JCO at ESMO 2026: Phase 2 Neoadjuvant Cemiplimab in CSCC: Final Analysis

A recent study presented at the ESMO 2026 Congress and published in the Journal of Clinical Oncology explores the use of neoadjuvant immunotherapy, specifically semiplimab, for patients with advanced cutaneous squamous cell carcinoma. Professor Neil Gross, Director of Clinical Research at MD Anderson Cancer Center, emphasizes the need for improved treatment options for this underserved patient population, which has historically received limited attention compared to melanoma skin cancers.

The phase two trial involved administering up to four doses of semiplimab prior to surgery. Results showed that 51% of patients achieved a complete pathological response, with long-term follow-up indicating that these responses are durable. The study raises questions about the necessity of further treatment for patients who achieve a complete response, as many experienced no recurrences without additional therapy. Gross notes that the neoadjuvant approach not only has the potential to reduce surgical morbidity but also allows for better assessment of treatment efficacy before surgery.

The discussion also highlights the challenges of identifying reliable biomarkers for predicting patient responses to neoadjuvant treatment. While early immune activation after one cycle of semiplimab may indicate a positive response, no definitive biomarkers have been established yet. The ongoing phase three trial aims to address these gaps and incorporate quality of life measures, which have been notably absent in previous studies for this patient group. Overall, the findings underscore the promise of neoadjuvant immunotherapy in improving outcomes for patients with cutaneous squamous cell carcinoma.

What long-term outcomes can be achieved with neoadjuvant cemiplimab, and how does immunotherapy reshape the treatment landscape for advanced cutaneous squamous cell carcinoma? Host Dr. Davide Soldato interviews Dr. Neil Gross on his simultaneous publication presented at ESMO 2026 "A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II–IV Cutaneous Squamous Cell Carcinoma: Final Analysis." They explore the clinical rationale, long-term survival and durability outcomes, and the profound impact of this approach on surgical morbidity and patient quality of life. Dr. Gross also shares insights on how these results are paving the way for ongoing randomized trials and the future of treatment personalization in advanced skin cancers.