FDA Approves Cemiplimab for Advanced Basal Cell Carcinoma

The FDA approved cemiplimab-rwlc (Libtayo) as the first immunotherapy for use in patients with advanced basal cell carcinoma (BCC) that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.

The regulatory decision was based on data from an open-label, multicenter, non-randomized phase 2 trial, which included a total of 132 patients with unresectable locally advanced BCC or metastatic BCC, either nodal or distant.

A total of 112 patients were included in the efficacy analysis. Of these patients, 28 had metastatic BCC and 84 had locally advanced BCC. Participants in both cohorts had either progressed on HHI therapy, had not achieved an objective response following 9 months of HHI treatment, or were intolerant of previous HHI therapy.

Results from the trial showed that cemiplimab elicited a confirmed objective response rate of 21% (95% CI, 8%-41%) in patients with metastatic BCC and 29% (95% CI, 19%-40%) in those with locally advanced BCC.

“Patients with advanced forms of basal cell carcinoma face a very difficult prognosis,” Peter Adamson, global development head of Oncology and Pediatric Innovation at Sanofi, stated in the press release. “Thanks to the participation and support of researchers, clinicians, and patients around the world, we are proud to bring forward a new immunotherapy treatment option for appropriate patients in the United States affected by advanced BCC, another devastating non-melanoma skin cancer.”