Libtayo data to form basis for US and EU submissions in BCC

French pharma major Sanofi (Euronext: SAN) has announced positive results from the pivotal Phase II trial for the PD-1 inhibitor Libtayo (cemiplimab) in locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy.

The results, which were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, will form the basis of regulatory submissions, including in the USA and the European Union (EU).

Alexander Stratigos, professor of dermatology at the University of Athens Medical School at Andreas Sygros Hospital and a trial investigator, said: “Advanced basal cell carcinoma can be an unrelenting, highly disfiguring disease, and there are no approved treatment options once a patient progresses on or becomes intolerant to HHIs.