The approval of its use was based on the results of the EMPOWER-Lung 1 study, a phase III trial that compared the efficacy of cemiplimab alone with that of platinum-based chemotherapy in patients with advanced NSCLC with tumor PD-L1 (22C-3) expression of ≥50% with overall survival (OS) and progression-free survival (PFS) as the primary endpoints. This evidence concerns the gene CD274 and neoplasm.