SITC 2020: Cemiplimab for Resistant Metastatic Basal Cell Carcinoma
Posted: Monday, November 23, 2020
For patients with metastatic or locally advanced basal cell carcinoma who are ineligible for surgery or radiation therapy, vismodegib, sonidegib, and Hedgehog inhibitors are often used for treatment. Though there is no approved treatment for individuals who are intolerant to or experience disease progression on Hedgehog inhibitors, Karl Lewis, MD, of the University of Colorado Hospital, Aurora, and colleagues devised a study to treat these patients with the anti–PD-1 inhibitor cemiplimab. These results were presented during the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 428) and published in the Journal for ImmunoTherapy of Cancer.
“This interim analysis demonstrates that cemiplimab is the first agent to provide clinically meaningful antitumor activity, including durable responses, in patients with metastatic basal cell carcinoma after progression or intolerance on Hedgehog inhibitor therapy,” the investigators concluded.
In this phase II study, 28 patients with metastatic basal cell carcinoma who discontinued Hedgehog inhibitor therapy due to disease progression, intolerance, or lack of improvement after 9 months were enrolled. They received 350 mg of cemiplimab intravenously every 3 weeks for about 57 weeks. Objective response rate, duration of response, safety and tolerability, progression-free survival, and overall survival were assessed.
A total of 21.4% of patients had a partial response. The objective response rate was 28.6%; the duration of response was 9 to 23 months; the median progression-free survival was 8.3 months; the median estimation of overall survival was 25.7 months; and the disease control rate was 67.9%.Common treatment-emergent adverse events were fatigue (50.0%), diarrhea (35.7%), pruritus (25.0%), and constipation (25.0%); hypertension, the only grade 3 adverse event, occurred in two patients. One patient died of staphylococcal pneumonia, but it was considered unrelated to study treatment.
Disclosure: For full disclosures of study authors, visit jitc.bmj.com.
