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 is1:

  • Locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or1
  • Metastatic1

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

ITT patient population (N=710)1

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

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

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

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.1-3
  • Platinum-based.1-3
  • ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; HR=hazard ratio; IHC=immunohistochemistry; ITT=intention-to-treat; NE=not evaluable; NR=not reached; NSCLC=non–small cell lung cancer; OS=overall survival; PD-L1=programmed death ligand 1; ROS1=ROS proto-oncogene 1, receptor tyrosine kinase.

Explore clinical data

Efficacy and safety profile in
patients who received LIBTAYO.1-3

View study results >

Review clinical study design

EMPOWER-Lung 1 was designed
to enroll advanced NSCLC
patients with PD-L1 ≥50%.1

View study design >

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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. Supplementary material available at: Accessed February 13, 2021. 3. PD-L1 IHC 22C3 pharmDx [instructions for use]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021.