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 and Google Scholar was completed for studies related to cosibelimab efficacy and safety in la and mCSCC. An expert panel of nine dermatologists with 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 six consensus statements, with five unanimously adopted with a strength of "A". CONCLUSION: Available data suggests 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.
Bartley et al. (Wed,) studied this question.