Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer

Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone.

The study focused on patients whose disease had progressed or whom were intolerant to prior hedgehog pathway inhibitor (HHI) therapy, a group which does not have access to any approved treatments. 

The findings indicated a 29% objective response rate (ORR) in patients with locally advanced disease, with 85% of responders achieving a duration of response (DOR) of at least one year. The durable disease control rate (DCR), measuring those patients who achieved a stable disease response lasting at least six months, was recorded as 60%.

In patients with metastatic disease, Libtayo showed an ORR of 21% and a durable DCR of 46%, with 83% achieving a DOR of at least one year. There were no new safety signals recorded; while 10 patients and nine patients died in the locally advanced and metastatic groups respectively, none of these were related to treatmet.

“While PD-1 inhibitors have transformed the outlook for many patients with melanoma, progress for patients with non-melanoma skin cancers has not been as rapid,” commented Dr Peter C Adamson, Global Head of Oncology Development at Sanofi. “We are continuing to address this unmet need by first bringing Libtayo to patients with advanced cutaneous squamous cell carcinoma, and now, with this second trial, as a potential therapy for patients with advanced basal cell carcinoma. These important new results further demonstrate Libtayo’s potential in patients with difficult-to-treat, non-melanoma skin cancers.”

Sanofi and Regeneron confirmed they plan to issue regulatory submissions this year.

Matt Fellows