Cemiplimab has ‘clinical benefit’ in locally advanced BCC after hedgehog inhibitor use

Patients previously treated with hedgehog inhibitors for locally advanced basal cell carcinoma saw “clinical benefit” when treated with cemiplimab, according to a presentation at South Beach Symposium Medical Dermatology Summit.

“Cemiplimab is an established therapy approved for treatment of advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or curative radiation,” Alexander J. Stratigos, MD, PhD, and colleagues wrote in the poster. “However, for patients with laBCC, there is no standard regimen after first-line HHI therapy.”

The phase 2 study enrolled 84 adults (men, 66.7%; median age, 70 years) with locally advanced basal cell carcinoma (laBCC) who discontinued hedgehog inhibitor (HHI) therapy, had at least one measurable lesion at baseline and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Among these patients, 71.4% discontinued HHI therapy due to disease progression, 38.1% were intolerant to therapy and 8.3% were “no better than stable disease” after 9 months of therapy. Patients received 350 mg of cemiplimab intravenously every 3 weeks. The study’s primary outcome measure was objective response rate. The median follow-up time was 15 months.

Objective response rate by independent central review was 31% (95% CI, 21.3-42). Among 26 patients with response, five had complete response and 21 had partial response.

The safety profile was “acceptable for the patient population” and was “generally consistent with other PD-1 antibodies and with previous reports of cemiplimab in other tumor types.” Among the study population, 51% of patients had an adverse event of grade 3 or greater, and 17% discontinued treatment due to a treatment-emergent adverse event. The most frequently reported treatment-related adverse events of grade 3 or higher were colitis (four cases), fatigue (two cases) and adrenal insufficiency (two cases).

“Cemiplimab is the first systemic therapy to show clinical benefit in patients with laBCC after HHI therapy,” the researchers wrote. “These results provide strong rationale for cemiplimab as a treatment option for patients with laBCC in the second-line (or greater) setting.”