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Sanofi/Regeneron Libtayo shows positive effect in skin cancer study

September 18, 2020

Sanofi (NASDAQ:SNY) presents positive results from the Phase 2 trial for the PD-1 inhibitor Libtayo (cemiplimab), jointly developed by Regeneron (NASDAQ:REGN), in patients with locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. BCC is a common type of non-melanoma skin cancer.

The data will form the basis of regulatory submissions, including in the U.S. and European Union.

Per independent central review, the objective response rate (ORR) was 31% among Libtayo-treated patients (n=84; 95% confidence interval [CI]: 21-42%).

Median follow-up of 15 months (range: 1-25 months). This included a 6% (n=5) complete and 25% (n=21) partial response rate, an increase from the ORR reported in May. As of data cut-off, the median duration of response and median overall survival had not yet been reached.

At one-year, 85% of responses were ongoing (95% CI; 61-95%), the probability of progression-free survival was 57% (95% CI: 44-67%), and the probability of overall survival was 92% (95% CI: 84-97%), according to Kaplan-Meier estimates.

No new Libtayo safety signals were observed.

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells.

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