What role, if any, do biomarkers play in selecting appropriate patients for neoadjuvant cemiplimab in cutaneous squamous cell carcinoma?  

Cutaneous squamous cell carcinoma (CSCC) is primarily a UV radiation driven malignancy and harbors many mutations. These cancers generally respond very favorably to PD-1 pathway inhibition, and thus biomarkers do not currently play a role in patient selection for neoadjuvant cemiplimab in CSCC. In t...

As of now, there is no predictive biomarker for predicting who will respond to cemiplimab in the metastatic setting, much less the neoadjuvant setting. Both PD-L1 and TMB have been unrevealing. Ongoing studies are looking at different tissue and plasma-based assays but remain experimental.

While it is known that cutaneous squamous cell carcinoma carries a high mutation burden, there are no studies that have found a biomarker of great clinical interest. In our proposed OSUCCC study, we plan to perform correlative studies for such biomarker. It would be especially important to find a bi...