ITT patient population (N=710)1
(95% CI, 17.7-NE) vs 14.3 months
(95% CI, 11.7-19.2) (chemotherapy†),
Number of deaths: 30% of patients (108 out of 356 patients) with LIBTAYO and 40% of patients
(141 out of 354 patients) with chemotherapy1
Known PD-L1 ≥50% patient population (n=563)2,3
(95% CI, 17.9-NE) vs 14.2 months
(95% CI, 11.2-17.5) (chemotherapy†),
Number of deaths: 25% of patients (70 out of 283 patients) with LIBTAYO and 38% of patients
(105 out of 280 patients) with chemotherapy2,3
NCCN Guidelines® for Non-Small Cell Lung Cancer recommend cemiplimab-rwlc (LIBTAYO) as a Category 1§ (preferred) systemic therapy option for advanced NSCLC5||
§Category 1 recommendation is based upon high-level evidence and uniform NCCN consensus that the intervention is appropriate.5
||See the NCCN Guidelines for detailed recommendations, including other preferred options. NCCN definition of advanced NSCLC does not include locally advanced NSCLC.5 NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
ALK=anaplastic lymphoma kinase; CI=confidence interval; EGFR=epidermal growth factor receptor; FDA=Food and Drug Administration; HR=hazard ratio; IHC=immunohistochemistry; ITT=intention-to-treat; NCCN=National Comprehensive Cancer Network; NE=not evaluable; NR=not reached; OS=overall survival; PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1; ROS1=ROS proto-oncogene 1, receptor tyrosine kinase.
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. PD-L1 IHC 22C3 pharmDx [instructions for use]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021. 4. 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. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.6.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed October 13, 2021. To view the most recent and complete version of the guidelines, go online to NCCN.org.