Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Libtayo® (cemiplimab) as monotherapy in two advanced cancers. The CHMP recommended the approval of Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. Libtayo was also recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). The European Commission is expected to make a decision on both indications in the coming months. The positive opinion for Libtayo in advanced NSCLC is based on results from a Phase 3 trial, which allowed for the enrollment of patients with disease characteristics frequently underrepresented in advanced NSCLC pivotal trials, including those with pre-treated and clinically stable brain metastases or locally advanced NSCLC and who were not candidates for definitive chemoradiation. Results from the pivotal trial were published in The Lancet in February 2021. The positive opinion for Libtayo in locally advanced and metastatic BCC is based on results from the largest prospective clinical trial in these patients previously treated with an HHI to date, with data presented at the European Society for Medical Oncology Virtual Congress 2020 and recently published in The Lancet Oncology. Libtayo is the first immunotherapy to receive a positive CHMP opinion for this indication. Libtayo is currently approved in the European Union (EU) and other countries for the treatment of certain patients with advanced cutaneous squamous cell carcinoma (CSCC).
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