Sanofi, Regeneron's Libtayo cleared for basal cell carcinoma

Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) has won a green light in Europe as the first immunotherapy to treat adults with locally advanced or metastatic basal cell carcinoma (BCC).

Specifically, the drug has been approved to treat patients who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).

BCC is the most common type of skin cancer worldwide, representing up to 80% of non-melanoma skin cancers, and incidence is increasing across many European countries.

The vast majority of BCCs are caught early and easily cured with surgery and/or radiation, but a small proportion of cases can develop into advanced forms of the disease, penetrating deeper into surrounding tissues or spreading to other parts of the body, thus becoming more difficult to treat.

Libtayo's approval in BCC follows data showing an objective response rate (ORR) of 32% by independent central review and 29% by investigator assessment.

Also, around 90% of patients across both groups had a duration of response (DOR) of six months or longer, and the median DOR has not been reached for either group.

“Libtayo is the first immunotherapy to show a clinical benefit in patients with advanced BCC after HHI therapy in a pivotal trial, and with this first-in-class approval has the potential to transform treatment for patients in Europe whose cancer has progressed despite HHI treatment,” said Israel Lowy, senior vice president, Translational and Clinical Sciences, Oncology at Regeneron.

“We look forward to continuing to investigate this medicine in additional settings, with the goal of helping more patients with difficult-to-treat cancers around the world.”

Libtayo is now approved for three advanced cancers in the EU: BCC, non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma (CSCC).