Libtayo (cemiplimab) is a fully-human monoclonal antibody (mAb) that targets the immune checkpoint receptor PD-1 and is the only treatment approved in advanced cutaneous squamous cell carcinoma (CSCC) in the European Union (EU).
The drug is being jointly investigated by Regneron and Sanofi under a global collaboration agreement between the two companies. Libtayo was developed by Regeneron using its proprietary VelocImmune technology.
Approval from the European Commission (EC) is based on data from a Phase II trial and is conditional. Per the conditional approval, Regeneron and Sanofi will add a new patient group to its clinical trial cohort to further support the benefit-risk profile of Libtayo and will report the results to the European Medicines Agency (EMA).
According to the companies, CSCC is one of the most commonly diagnosed skin cancers and the incidence is estimated to be increasing in European countries. The EC noted in its approval that there is an “extreme unmet need” for treatment of advanced CSCC.
The companies explained that patients with advanced or metastatic CSCC often have a life expectancy of one year based on historical data.
Libtayo has been approved in the US, Canada, and Brazil for patients with metastatic or locally advanced CSCC.
Currently, Libtayo is also being investigated for the treatment of non-small cell lung cancer, basal cell carcinoma, and cervical cancer, and in adjuvant and neoadjuvant trials in CSCC.
The market for PD-1 inhibitors is growing with companies like Eli Lilly jointly developing Tyvyt (sintilimab) in China, Merck’s Keytruda, Bristol-Myers Squibb’s collaborative Opdivo (nivolumab), and other drug products entering the global market.