In patients who had no EGFR, ALK, or ROS1 aberrations:
EGFR, ALK, or ROS1 genomic tumor abberations; a medical condition that required systemic immunosuppression; uncontrolled infections with hepatitis B, hepatitis C, or HIV; autoimmune disease that required systemic therapy within 2 years of treatment; and never-smokers.
Primary endpoints1
OS and PFS
Secondary endpoints included1,2
ORR (key), DOR, and safety and tolerability
All primary and secondary analyses were conducted per blinded independent central review.1,2
In the LIBTAYO arm (ITT patient population) at baseline, 12% of patients had treated and clinically stable brain metastases,* 18% had locally advanced disease, and 2% had controlled hepatitis B or hepatitis C. Patients with HIV were permitted to enroll, but none were recruited.1,2,4
Explore Hypothetical Patient Profiles
References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. 3. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274)(suppl):1-178. 4. Data on file. Regeneron Pharmaceuticals, Inc.