Multinational phase 3 study of addition of cemiplimab to first-line chemotherapy for advanced non-small cell lung cancer

First-line cemiplimab (anti-PD-1) monotherapy has previously shown significant improvement in PFS and OS versus chemotherapy in patients with advanced non-small cell lung cancer (aNSCLC) and PD-L1 expression ≥ 50%. The multinational phase 3 EMPOWER-Lung 3 trial evaluated first-line cemiplimab plus platinum-doublet chemotherapy versus placebo plus chemotherapy for aNSCLC irrespective of PD-L1 expression or histology. The primary end point was OS. The trial was stopped early per recommendation of th IDMC based on meeting preset OS efficacy criteria: median OS was 21.9 months in the cemiplimab plus chemotherapy group versus 13.0 months in the placebo plus chemotherapy group (HR 0.71; p=0.014). Grade 3 or higher adverse events were seen in 43.6% of patients with cemiplimab plus chemotherapy and 31.4% of patients with placebo plus chemotherapy.