Cemiplimab has ‘increasing, clinically meaningful’ duration of response in advanced cSCC
Click Here to Manage Email Alerts
Patients with advanced cutaneous squamous cell carcinoma had an “increasing, clinically meaningful” duration of response with cemiplimab, according to results from a phase 2 study presented at Maui Derm for Dermatologists.
“Cemiplimab is a high-affinity, highly potent, human immunoglobulin G4 monoclonal antibody to the programmed cell death-1 receptor,” Danny Rischin, MBBS, FRACP, MD, and colleagues wrote in the poster. “We present up to 3-year follow-up (median duration of follow-up for all patients: 15.7 months) from the largest and most mature prospective data set in advanced cSCC.”
Rischin and colleagues conducted the EMPOWER-CSCC-1 open-label, non-randomized, multicenter, international phase 2 study, which enrolled 193 patients (median age, 72 years; men, 83.4%) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and “adequate organ function” into three groups. Fifty-nine patients with metastatic cutaneous squamous cell carcinoma (cSCC) (group 1) and 78 patients with locally advanced cSCC (group 2) received cemiplimab 3 mg/kg every 2 weeks for up to 96 weeks and tumor imaging every 8 weeks. Fifty-six patients with metastatic cSCC (group 3) received cemiplimab 350 mg every 3 weeks for up to 54 weeks and tumor imaging every 9 weeks. The primary outcome measure was the objective response rate (ORR) by independent central review (ICR).
The ORR per ICR for all three groups was 46.1% (95% CI, 38.9-53.4). ORR was highest in group 1 (ORR = 50.8%; 95% CI, 37.5-64.1), followed by group 2 (ORR = 44.9%; 95% CI, 33.6-56.6) and then group 3 (42.9%; 95% CI, 29.7-56.8).
The median time to complete response was 11.2 months. The number of patients with complete response increased from primary follow-up in group 1 (primary, n = 4; 1 year, n = 10; 2 years, n = 12) and group 3 (primary, n = 3; 1 year, n = 9) and remained consistent from primary to 1 year in group 2 (n = 10).
With median duration of response not reached after 1 year of follow-up, the researchers said this “indicates an increasing, clinically meaningful [duration of response] with cemiplimab.”