Advanced Non-Small Cell Lung Cancer

LIBTAYO is indicated for the first-line treatment of patients with non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.1

See the results of the EMPOWER-Lung 1 trial

VIEW THE CLINICAL DATA FOR LIBTAYO
Libtayo Advanced NSCLC Hypothetical Patient Portrayal Nora Libtayo Advanced NSCLC Hypothetical Patient Portrayal Nora

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) with LIBTAYO vs 14.3 months
(95% CI, 11.7-19.2) with chemotherapy
32%

Reduction in risk of death HR=0.68

(95% Cl, 0.53-0.87)
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: Not Reached
(95% CI, 17.9-NE) with LIBTAYO vs 14.2 months
(95% CI, 11.2-17.5) with chemotherapy
43%

Reduction in risk of death HR=0.57

(95% Cl, 0.42-0.77)
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
PD-L1 expression was determined using the PD-L1 IHC 22C3 pharmDx assay.1-3
  • All primary and secondary analyses were conducted per blinded independent central review.1-2
  • *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
  • HR based on stratified proportional hazards model.1,3
  • 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; MOA=mechanism of action; 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.