The European Commission has approved Libtayo (cemiplimab) as the first and only immunotherapy for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation.
The decision expands Libtayo’s existing indication in advanced CSCC to include earlier-stage patients, following similar approval by the US Food and Drug Administration in October.
Paolo Bossi, Head of the Head and Neck Medical Oncology Unit at Humanitas Cancer Center in Milan, explained: “While CSCC can often be treated successfully with surgery and radiation, some patients face the persistent threat of disease recurrence and potentially fatal outcomes.
“This highlights a critical need for earlier intervention, but immunotherapy has until now been reserved just for advanced cases.” He added: “As the only immunotherapy shown to improve disease-free survival in this setting, Libtayo could change the outlook for these earlier-stage patients in need.”
The approval is based on results from the global phase 3 C-POST trial, which showed that Libtayo reduced the risk of recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20–0.51; p<0.0001).
George D Yancopoulos, Board co-Chair, President and Chief Scientific Officer of Regeneron, said: “CSCC is one of the fastest-growing forms of skin cancer, and the approval of Libtayo by the European Commission reflects a meaningful shift in how this disease could be treated in the adjuvant setting.”
He continued: “Building on our existing indication in advanced CSCC, this is the sixth approval for Libtayo in the European Union and underscores our commitment to delivering innovative treatments across cancers where patients continue to face some of the greatest gaps in care.”
