Sanofi and Regeneron’s Libtayo (cemiplimab) has demonstrated ‘clinically meaningful and durable responses’ in a subset of patients with basal call carcinoma (BCC) from whom there are currently no approved treatments.
The companies released topline data for a pivotal, single-arm, open-label trial testing the PD-1 inhibitor in patients with advanced BCC who had progressed on or were intolerant to prior hedgehog pathway inhibitor (HHI) therapy.
In the trial, the objective response rate (ORR) for patients with locally advanced disease was 29%, with an estimated duration of response (DOR) exceeding one year in 85% of responders. The durable disease control rate (DCR – response or stable disease lasting at least six months) was 60%.
In a preliminary analysis of patients with metastatic disease, the ORR was 21%, with an estimated DOR exceeding one year in 83% of responders. The durable DCR was 46%.
While the vast majority of BCCs are caught early and cured with surgery or radiation, a small proportion of tumours can become advanced and penetrate deeper into surrounding tissues (locally advanced), which is more difficult to treat.
BCC marks the second non-melanoma skin cancer for which Libtayo has demonstrated first-in-class data and follows its initial US approval in advanced cutaneous squamous cell carcinoma (CSCC) in 2018.
Sanofi and Regeneron plan regulatory submissions in 2020.
