Promising Phase 2 data for Sanofi and Regeneron's PD-1 inhibitor Libtayo in locally advanced basal cell carcinoma

Promising Phase 2 data has been released at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 for Sanofi and Regeneron’s jointly-developed PD-1 inhibitor Libtayo (cemiplimab) in the treatment of locally advanced basal cell carcinoma (BCC) in patients for whom hedgehog inhibitor (HHI) therapy is not applicable.

The presented findings revealed that patients receiving the therapy showed an objective response rate of 31% after a median follow-up of 15 months, including a partial response rate of 25% and a complete response rate of 6%, regardless of baseline tumour PD-L1 expression.

These responses were maintained for at least one year in 85% of participants, but median duration of response and median overall survival data had not matured sufficiently by the time of analysis; the probability of progression-free survival was given as 57% while probability of overall survival was recorded as 92%.

The results mark an improvement in overall response compared to data shared on the drug in this indication back in May, and no new safety signals were observed during the trial.  

“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 hedgehog inhibitors,” explained Dr Alexander Stratigos, an investigator on the trial and Professor of Dermatology at the University of Athens Medical School at Andreas Sygros Hospital. “This is the first time a prospective trial of an investigational medicine has shown a clinical benefit in this patient population, and the Libtayo data provide hope for this difficult-to-treat cancer.”

Sanofi confirmed that these data will be submitted to regulatory authorities in the pursuit of market approval in the US and Europe.

Matt Fellows