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Karl D. Lewis, MD


AACR 2022: Cemiplimab-rwlc in Treatment of Basal Cell Carcinoma After Hedgehog Inhibition

By: Vanessa A. Carter, BS
Posted: Thursday, April 14, 2022

A phase II study, conducted by Karl Lewis, MD, of the University of Colorado School of Medicine, Aurora, and colleagues, evaluated the clinical benefit and safety profile of the monoclonal antibody cemiplimab-rwlc in patients with metastatic basal cell carcinoma who discontinued Hedgehog inhibitor therapy. Presented during the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract CT165/8), these results indicated cemiplimab not only showed clinically meaningful antitumor activity, but it also demonstrated an acceptable safety profile in this cohort.

This trial enrolled 54 patients with metastatic basal cell carcinoma who had disease progression on or were intolerant to Hedgehog inhibitor therapy. Participants were administered 350 mg of intravenous cemiplimab every 3 weeks for up to 93 weeks or until progressive disease.

Many patients (70.4%) were male, and the median patient age was 63.5; two-thirds of participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, and the remaining third had an ECOG performance status score of 1. The objective response rate per independent central review was 25.9%, consisting of 2 complete and 12 partial responses. With a median time to response of 4.0 months, the estimated duration of response was 16.7 months.

The disease control rates per independent central review and per investigator were 63.0% and 70.4%, respectively; the median progression-free survival per independent central review was 8.3 months.

Fatigue (37.0%) was the most common treatment-related adverse event, followed by diarrhea (14.8%), pruritus (13.0%), arthralgia (9.3%), and hyperthyroidism (9.3%). Constipation, asthenia, maculopapular rash, and hypothyroidism each affected 7.4% of patients, and no treatment-related deaths were observed.

Disclosure: Disclosure information was not provided.

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