A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of Groups 1, 2, and 3, and primary analysis of fixed-dose treatment Group 6

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In this phase 2, open-label, observational, non-randomized multi-cohort study (NCT02760498) we report the final analysis of weight-based cemiplimab monotherapy (3 mg/kg intravenous [IV] every 2 weeks) in metastatic cutaneous squamous cell carcinoma (mCSCC, Group 1) and locally advanced cutaneous squamous cell carcinoma (laCSCC, Group 2), fixed-dose (350 mg IV every 3 weeks) cemiplimab in mCSCC (Group 3), and the primary analysis of fixed-dose (350 mg IV every 3 weeks) cemiplimab in mCSCC/laCSCC (Group 6). The primary efficacy endpoint was objective response rate (ORR; defined as complete response + partial response) per independent central review in each group. Secondary endpoints were estimated ORR per investigator’s assessment; complete response per independent central review; duration of response, progression-free survival, and overall survival by independent central review and investigator’s assessment. Safety assessments included immune-related treatment-emergent adverse events and treatment-emergent adverse events (graded by the National Cancer Institute Common Terminology Criteria for Adverse Events v.4.03). This study represents the largest prospective data set for patients with advanced CSCC treated with anti-programmed cell death-1 therapy. Cemiplimab demonstrated clinically meaningful activity in patients with mCSCC and laCSCC, regardless of biomarker status and age. The final analysis of Groups 1–3 demonstrated prolonged duration of response in the longest follow-up reported so far, while the primary analysis of Group 6 confirmed the clinical activity of cemiplimab at a fixed dose. The safety profile for cemiplimab was generally consistent with data reported for other anti-programmed cell death-1/programmed cell death-ligand 1 agents. Currently, cemiplimab monotherapy is the current standard-of-care option for patients with advanced CSCC ineligible for curative surgery or radiation. The results of this study support the use of cemiplimab in advanced CSCC.

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