Regeneron Pharmaceuticals’ Libtayo (cemiplimab) has received approval from the European Commission for the adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) with high risk of recurrence after surgery and radiation.
A phase 3 trial showed that Libtayo was the first immunotherapy to significantly improve disease-free CSCC survival in the adjuvant setting. When tested in patients with a high risk of cancer recurrence following surgical or radiological treatments, it was shown to reduce the risk of disease recurrence or death by 68% compared to placebo.
CSCC, a form of non-melanoma skin cancer (NMSC), is one of the most common cancers in the world. The incidence of NMSC in the EU is projected to increase by 40% in the coming decades. While CSCC can often be treated successfully through surgery or radiation, some patients face a high-risk, recurring form of the cancer.
“While CSCC can often be treated successfully with surgery and radiation, some patients face the persistent threat of disease recurrence and potentially fatal outcomes,” said Paolo Bossi, head of the Head and Neck Medical Oncology Unit and associate professor of medical oncology, Humanitas University and Humanitas Cancer Center, Milan, Italy.
“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.”
Libtayo’s safety profile as an adjuvant treatment for CSCC is consistent with its safety profile as a monotherapy for the treatment of other cancers.
George Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, said: “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.”