Use of Cemiplimab for Locally Advanced Cutaneous Squamous Cell Carcinoma
Posted: Thursday, February 13, 2020
According to findings published in The Lancet Oncology, the monoclonal antibody cemiplimab demonstrated antitumor activity and an “acceptable” safety profile for patients with locally advanced cutaneous squamous cell carcinoma. The results of the single-arm phase II trial are particularly notable because there is currently no widely accepted standard of care for this patient pool, according to Michael R. Migden, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues.
“This analysis provides clinically meaningful data on disease control and the estimated proportion of patients who were alive at 12 months in a population of patients who, in the absence of effective treatment, often have poor prognosis,” the authors concluded.
In this open-label trial, the investigators enrolled 78 patients from academic medical centers in Australia, Germany, and the United States. Patients had histologically confirmed locally advanced cutaneous squamous cell carcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1. Those enrolled were treated with 3 mg/kg of cemiplimab intravenously for 30 minutes every 2 weeks for up to 96 weeks.
After a median follow-up of 9.3 months, 34 patients exhibited an objective response (44%), with 10 patients achieving a complete response (13%) and 24 reaching a partial response (31%). Grade 3 to 4 treatment-emergent adverse events occurred in 34 patients (44%), with hypertension and pneumonia being the most common (6 and 4 patients, respectively). Serious treatment-emergent adverse events occurred in 23 patients (29%), and one treatment-related death was reported after the onset of aspiration pneumonia.
“The fixed-dose equivalent (cemiplimab at 350 mg every 3 weeks) approved by the FDA and European Commission has been shown to have similar pharmacokinetics to weight-based dosing and is being examined in a separate cohort of patients in a phase II study (ClinicalTrials.gov identifier: NCT02760498),” the authors noted.
Disclosure: For full disclosures of the study authors, visit thelancet.com.