The drug, Libtayo (cemiplimab), was approved by the US Food and Drug Administration (FDA) for the treatment of advanced cutaneous squamous cell carcinoma (CSCC), a common form of skin cancer. Libtayo is a human monoclonal antibody targeting the immune checkpoint receptor PD-1.
Both Regeneron and Sanofi told us that CSCC can be difficult to treat effectively when it becomes advanced, and patients can experience significant health issues as the disease progresses.
It is the first drug to come out of the 2015 partnership between the two companies, which aimed to jointly develop a PD-1 inhibitor. Through the deal, the two companies invested $1bn (€865m) for the discovery of potential therapies. The agreement was set to last five years, and this approval came in its third.
“Like many in the industry, we believe that PD-1s will be a backbone of immunotherapy treatment in cancer, and are approaching our IO research with a proven model of innovation honed through more than a decade of collaboration. The FDA approval of Libtayo in advanced CSCC is a testament to this. In three years, we were able to progress Libtayo from its first clinical trial to its first FDA approval,” a spokesperson from Regeneron told us.
Both companies told us that Libtayo’s approval was based upon positive Phase II trial data, in which patients received 3mg every two weeks for up to 96 weeks, and an expansion of a Phase I trial in which patients received the same dose every two weeks for up to 48 weeks.