Topline data from the pivotal, single-arm, open-label trial of cemiplimab (Libtayo) in patients with advanced basal cell carcinoma (BCC) who had progress on or were intolerant to prior hedgehog pathway inhibitor (HHI) therapy were announced by Sanofi and Regeneron, the developers of the PD-1 inhibitor.
Cemiplimab showed clinically meaningful and durable responses in this group of patients for whom there are no currently approved treatments. The companies indicated that they anticipate regulatory submissions sometime in 2020.
BCC is the second non-melanoma skin cancer for which cemiplimab has demonstrated first-in-class data, as the agent was initially approved in the US, EU, and other countries for advanced cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
“While PD-1 inhibitors have transformed…