Cemiplimab Therapy Safe, Active in Patients With Cutaneous Squamous Cell Carcinoma

Phase 2 study findings demonstrated the acceptable safety profile and antitumor activity of cemiplimab therapy for patients with locally advanced cutaneous squamous cell carcinoma (Lancet Oncol. 2020;21[2]:294-305).

“Cemiplimab has shown substantial antitumour activity in patients with metastatic cutaneous squamous cell carcinoma. Patients with locally advanced cutaneous squamous cell carcinoma have poor prognosis with conventional systemic therapy,” explained Michael R. Migden, MD, Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, and co-investigators.

Thus, Dr Migden et al conducted an open-label, single-arm study to assess the safety and antitumor activity of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma.

A total of 78 patients were enrolled in the study from 25 outpatient clinics across Australia, Germany, and the United States between June 14, 2016, and April 25, 2018. All patients were given intravenous cemiplimab 3 mg/kg over 30 minutes every 2 weeks for up to 96 weeks.

The primary end point of the trial was objective response (OR; ie, patients with complete or partial responses). Dr Migden and colleagues measured patient tumors every 8 weeks and conducted analyses in an intention-to-treat manner.

October 10, 2018, was the point of data cutoff, and represented when the entire cohort reached the prespecified timepoint for the primary analysis.

Follow-up lasted for a median duration of 9.3 months, by which point 34 (44%) patients had ORs (95% CI, 32-55). According to Dr Migden et al, the best OR was 10 (13%) patients and 24 (31%) patients with complete and partial responses, respectively.

Overall, 34 (44%) patients had treatment-emergent adverse events (TEAEs) grade 3-4; the most frequently reported TEAEs were hypertension in 6 (8%) patients and pneumonia in 4 (5%). There were 23 (29%) patients who had serious TEAEs, and 1 treatment-related death occurred following an onset of aspiration pneumonia.

“Cemiplimab showed antitumour activity and an acceptable safety profile in patients with locally advanced cutaneous squamous cell carcinoma for whom there was no widely accepted standard of care,” Dr Migden and colleagues concluded.—Hina Porcelli