Pts received fianlimab 1600 mg + cemi 350 mg intravenously every 3 weeks (wks) for 12 mo....In EC1, the ORR for treatment-naive pts (n=6) was 50%; the ORR for pts with PD-L1 expression ≥50% (n=3) was 100%. Kaplan–Meier estimation of median progression-free survival was 2.6 mo (95% confidence interval [CI], 1.2–8.3) in EC1 and 4.1 mo (95% CI, 1.3–6.2) in EC2 pts....Fianlimab + cemiplimab demonstrated promising signs of clinical activity with durable responses among pts with anti–PD-1/L1-naive NSCLC and in pts with PD-L1 expression ≥50%, with a similar safety profile and with no new safety signals compared to cemiplimab monotherapy.