Efficacy of Cemiplimab as Adjuvant or Neoadjuvant Therapy in the Treatment of Cutaneous Squamous Cell Carcinoma
Andrea R. Hiller*1, Jeffrey Fornadley1, Alexis Lo1, Madison Oxford2, Pallavi Kulkarni2, Akshilkumar Patel1, Jeff Sivik3, Kavita Vakharia1
1Surgery, Penn State Health Milton S. Hershey Medical Center, Hummelstown, PA; 2Penn State College of Medicine, Hershey, PA; 3Pharmacy, Penn State Milton S. Hershey Medical Center, Hershey, PA
Cutaneous squamous cell carcinoma (cSCC) is the second most common skin cancer. Unfortunately, the prognosis of advanced cSCC is poor, and management can be challenging. Until recently, the choice of systemic medications was limited and those that were available had modest efficacy. Cemiplimab is an anti-programmed cell-death protein-1 (PD-1) inhibitor and the first immunotherapeutic agent approved for the treatment of metastatic or locally advanced cSCC. The purpose of this study was to evaluate the efficacy of Cemiplimab when used as adjuvant or neoadjuvant therapy in patients treated at our institution.
A retrospective review of patients with locally advanced or metastatic cSCC treated who were treated with Cemiplimab as adjuvant or neoadjuvant therapy at a single institution between February 2019 and November 2022 was performed. Response to treatment was objectively assessed based on RECIST1.1 criteria. The primary end point was objective response rate (ORR). Secondary endpoints included time to observed response, disease-control rate (DCR), progression-free survival (PFS) and toxicity.
A total of 6 patients were identified with a with a median age of 79 (range 51-90). Four patients had locally advanced cSCC and 2 had distant metastasis. Cemiplimab was used as adjuvant therapy in 3 patients, neoadjuvant in 2 patients and as limb salvage for unresectable disease in 1 patient. ORR, complete response (CR), and partial response (PR) were 66% (4/6), CR 33% (2/6) and PR 33% (2/6). Average time to observed response was 2.9 months. DCR was 83% (5/6) and average PFS was 10 months. Toxicity was reported in 2 patients, both of which were grade 1 severity.
Cemiplimab has established its utility in the treatment of advanced cSCC, demonstrating partial and complete responses, while generally having a tolerable adverse effect profile. Further studies are needed to look at the usage of cemiplimab as a neoadjuvant or adjuvant treatment to surgical excision to determine its efficacy and safety profile used in this setting.
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