Efficacy and Safety of Cosibelimab for Advanced Cutaneous Squamous Cell Carcinoma: An Expert Consensus Panel

Background: Cutaneous squamous cell carcinoma (cSCC) represents a significant clinical challenge in patients with locally advanced (laCSCC) or metastatic (mCSCC) disease who are not candidates for surgery or radiation. In addition to PD-1 inhibitors, pembrolizumab and cemiplimab, cosibelimab, a PD-L1 inhibitor, has been recently approved by the US Food and Drug Administration (FDA) for laCSCC and mCSCC. Given its recent approval, practical guidance is needed to support clinician decision-making regarding cosibelimab’s efficacy and safety. Methods: A comprehensive literature review of PubMed andDoGoogleNot CopyScholar was completed for studies related to cosibelimab efficacy and safety in laCSCC and mCSCC. An expert panel of 9 PenaltiesdermatologistsApplywith significant expertise in the treatment of cSCC gathered to review the articles and create consensus statements on the role of cosibelimab in managing laCSCC and mCSCC. A modified Delphi process was used to approve each statement, and the strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria. Results: The literature search produced over 200 articles that met the criteria, and a screening of the studies for relevance resulted in 13 articles. The panel developed 6 consensus statements, with 5 unanimously adopted with a strength of “A”. Conclusion: Available data suggest that cosibelimab is an effective treatment for patients with laCSCC and mCSCC who are not candidates for surgery or radiation. Cosibelimab demonstrates a unique and favorable safety profile with no reported grade 4 or 5 immune-related adverse events after more than 2 years of follow-up.