Overall survival with LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 11-3*

ITT patient population (N=710)1

Median OS: 22.1 months

(95% CI, 17.7-NE) vs 14.3 months
(95% CI, 11.7-19.2) (chemotherapy),
HR=0.68, P=0.00221

32% reduction in risk of death; HR=0.68, P=0.00221

Number of deaths: 30% of patients (108 out of 356 patients) with LIBTAYO and 40% of patients
(141 out of 354 patients) with chemotherapy1

The EMPOWER-Lung 1 study was designed to enroll patients with PD-L1 ≥50%.2
  • A total of 710 patients were enrolled and randomized. For some patients, it was later determined that PD-L1 biomarker testing was not conducted according to the instructions for use, and required retesting2
  • An analysis was conducted in a subset of patients with known PD-L1 ≥50% (n=563). The analysis excluded 91 patients from the overall population whose PD-L1 status was unknown because their tumors could not be retested, and 56 patients from the overall population who had <50% PD-L1 expression2 (LIBTAYO is not indicated in patients with <50% PD-L1 expression)

Known PD-L1 ≥50% patient population (n=563)2,3

Median OS: NR

(95% CI, 17.9-NE) vs 14.2 months
(95% CI, 11.2-17.5) (chemotherapy),
HR=0.57, P=0.00022,3

43% reduction in risk of death; HR=0.57, P=0.00022,3

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

  • *Investigator’s choice: Paclitaxel + cisplatin or carboplatin; gemcitabine + cisplatin or carboplatin; or pemetrexed + cisplatin or carboplatin followed by optional pemetrexed maintenance in patients with nonsquamous histology.1-4
  • Platinum-based.1-3

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)5

NCCN Guidelines® for Non-Small Cell Lung Cancer recommend cemiplimab-rwlc (LIBTAYO) as a Category 1 (preferred) systemic therapy option for advanced NSCLC

Category 1 (preferred) recommendation5
PD-L1–POSITIVE (≥50%) ADVANCED NSCLC5 A preferred PD-1 inhibitor5

Negative for actionable molecular markers and no
contraindications to PD-1 or PD-L1 inhibitors5

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. Advanced NSCLC does not include locally advanced disease.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; EGFR=epidermal growth factor receptor; 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.

Help eligible patients access LIBTAYO and
navigate the health insurance process.

Learn about the LIBTAYO Surround Patient Support Program

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.5.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 16, 2021. To view the most recent and complete version of the guidelines, go online to NCCN.org.