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Locally Advanced Basal Cell Carcinoma: Use of Cemiplimab-rwlc After Hedgehog Inhibitor Therapy

By: Susan Reckling
Posted: Tuesday, July 6, 2021

Investigators have long sought an effective treatment regimen for patients whose locally advanced basal cell carcinoma progresses after first-line therapy with a Hedgehog inhibitor (eg, vismodegib, sonidegib), with little success. However, according to the findings of a recent open-label, multicenter, single-arm trial, the PD-1 inhibitor cemiplimab-rwlc appears to be active in this patient population. Alexander J. Stratigos, MD, PhD, of National and Kapodistrian University of Athens, and colleagues published their primary analysis of these phase II findings in The Lancet Oncology.

“Centrally reviewed objective response was observed in 31% of patients, with [an] estimated duration of response exceeding 1 year in 85% of responders,” the investigators reported.

The study focused on 84 patients treated with cemiplimab for locally advanced basal cell carcinoma from February 17, 2017, to January 7, 2019, across 38 outpatient clinics in Canada, Europe, and the United States. These patients either experienced disease progression on or were intolerant to previous therapy with a Hedgehog inhibitor (eg, vismodegib, sonidegib). The dose of cemiplimab was 350 mg intravenously every 3 weeks for up to 93 weeks or until disease progression of unacceptable toxicity.

At data cutoff (February 2020), the median duration of follow-up was 15 months. The rate of objective response per independent central review—the primary study endpoint—was 31% (95% confidence interval = 21%–42%). The best overall response was a complete response in five patients (6%) and a partial response in 21 patients (25%).

In terms of toxicity, approximately half of the patients (48%) experienced grade 3 or 4 treatment-emergency adverse events. The most common side effects were hypertension and colitis. A total of 35% of study patients were observed to have serious treatment-emergency adverse events, but no treatment-related deaths were reported.

Disclosure: For disclosures of the study authors, visit

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