EMPOWER-Lung 1 PHASE3 COMPLETED n=710
Drug: Libtayo · REGN
Study Design
DesignRandomized, open-label, active-controlled, multicenter
Randomization1:1
BlindingOpen-label
Enrollment710
Treatment Arms
Cemiplimab 350mg Q3W 350mg IV Q3W n=356
Platinum-doublet chemotherapy Investigator-choice platinum-doublet n=354
Primary Endpoints
[{"id":"lung1-os","name":"Overall Survival (OS)","type":"CO_PRIMARY","unit":"months","results":[{"notes":"Median OS 26.1 months","value":26.1,"arm_id":"cemiplimab-lung1","arm_name":"Cemiplimab"},{"value":13.3,"arm_id":"chemo-lung1","arm_name":"Chemo"},{"value":0.57,"arm_id":"hr","p_value":"0.0002","arm_name":"HR","ci_lower":0.42,"ci_upper":0.77}],"timepoint":"Event-driven","description":"Overall survival in advanced NSCLC with PD-L1 ≥50%."},{"id":"lung1-pfs","name":"Progression-Free Survival (PFS)","type":"CO_PRIMARY","unit":"months","results":[{"value":8.2,"arm_id":"cemiplimab-lung1","arm_name":"Cemiplimab"},{"value":5.7,"arm_id":"chemo-lung1","arm_name":"Chemo"},{"value":0.54,"arm_id":"hr","p_value":"<0.0001","arm_name":"HR","ci_lower":0.43,"ci_upper":0.68}]}]
Efficacy Results
OS 26.1 vs 13.3 months (HR 0.57, p=0.0002). PFS 8.2 vs 5.7 months (HR 0.54, p<0.0001). Strong monotherapy activity in PD-L1 ≥50% NSCLC.
Safety Results
EMPOWER-Lung 1 (n=710): Typical PD-1 profile. Pneumonitis 5%, hypothyroidism 12%.
Assessment
Strong OS benefit (HR 0.57) but Keytruda had already dominated this space commercially.
Background & Context
PD-L1 high NSCLC responds well to PD-1 monotherapy.
Data from Supabase · Updated 2026-03-24