Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma

Shaping the Future of Immunotherapy Targets and Biomarkers in Melanoma and Non-Melanoma Cutaneous Cancers

“…Indeed, Gross et al recently reported results of neoadjuvant cemiplimab in stage II to IV cSCC. The study demonstrated a 68% objective response rate, as well as a 51% pathological complete response rate, and a 13% pathological major response rate [ 124 ].…”

“…Ultraviolet exposure, with subsequent DNA damage that leads to a high tumor mutational burden (TMB), as well as a state of immunosuppression, is the main risk factors for cSCC development and interestingly, both factors correlate with superior response to immunotherapy [ 116 , 256 ]. In the recent decade, multiple trials confirmed the efficacy of ICI in various stages of the disease [ 117 , 118 , 124 , 257 , 258 , 259 ]. In most published studies, tumor response and survival subgroup analyses were mainly based on clinical characteristics, along with well-established biomarkers, such as TMB and PD-L1 status.…”

“…In most published studies, tumor response and survival subgroup analyses were mainly based on clinical characteristics, along with well-established biomarkers, such as TMB and PD-L1 status. PD-L1 positivity (>1%) is reported to correlate with better response to treatment, although up to 20% response rate was observed in PD-L1 negative (less than 1%) tumors [ 124 , 260 , 261 ]. Tumor mutations burden is considered to be generally high in cSCC, but nevertheless, this can vary significantly.…”

Recent Advances in Immunotherapy for Patients with Head and Neck Cutaneous Squamous Cell Carcinoma

“…In a study by Ferraroto et al involving 20 patients with recurrent and resectable stage II-IV HNCSCC, 2 cycles of cemiplimab prior to surgery resulted in 11 pathologic CRs and 3 major pathologic responses [ 78 ]. A follow-up study published in 2022, involving 79 patients with operable stage II-IV HNCSCC, found that up to 4 doses of cemiplimab prior to surgery was associated with 51% of patients achieving pathologic CRs [ 79 ]. Interestingly, 68% of patients with a clinical partial response were found to have a complete pathological response, clinically underestimating the activity of cemiplimab in this patient population.…”

The greatest achievements in oncology in 2022 – melanoma and skin carcinomas

“…A phase II clinical trial demonstrated meaningful activity of cemiplimab and acceptable safety profile in the population of BCC – objective responses were observed in 31% of patients [ 12 ]. Even more striking results were achieved in a phase II clinical nonrandomized trial evaluating cemiplimab in neoadjuvant therapy in patients with resectable stage II, III, or IV (M0) cutaneous SCC [ 13 ]. In a group of 79 patients receiving cemiplimab preoperatively every 3 weeks with up to 4 doses, pathological complete responses were observed in 40 (51%) patients and MPR in 10 (13%) patients.…”