Patient portrayal
as a monotherapy or in combination with chemotherapy

Now Approved

In Combination with Chemotherapy

LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of adult patients with non–small cell lung cancer (NSCLC) 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

Review Empower-lung 3 clinical data

Approved

as a monotherapy

LIBTAYO as a single agent is indicated for the first-line treatment of adult patients with 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

REVIEW EMPOWER-LUNG 1 clinical data
LIBTAYO® (cemiplimab-rwlc) logo

Discover how LIBTAYO works

LIBTAYO is a human IgG4 anti–PD-1 monoclonal antibody.1 Learn how it may work in your advanced NSCLC patients.

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LIBTAYO alone and in combination with chemotherapy demonstrated overall survival benefit in two phase 3 pivotal trials vs chemotherapy1:

In patients with advanced NSCLC who had no EGFR, ALK, or ROS1 aberrations*

LIBTAYO + chemo vs chemo alone (N=466)1,2

Superior Median OS:
21.9 months
(95% CI, 15.5-NE) vs 13.0 months (95% CI, 11.9-16.1) with chemotherapy alone, HR=0.71, P=0.01401
  • Number of deaths in EMPOWER-Lung 3: 42% of patients (132 out of 312 patients) with LIBTAYO + chemotherapy and 53% of patients (82 out of 154 patients) with chemotherapy alone1

SAFETY DATA1,2

  • Serious adverse reactions occurred in 25% of patients. The most frequent serious adverse reactions that occurred in at least 2% of patients were pneumonia, anemia, and neutropenia.1
  • Fatal adverse reactions occurred in 6% of patients who received LIBTAYO in combination with chemotherapy [including death not otherwise specified (2.9%), sudden death (1.0%), acute hepatitis (0.3%), acute respiratory distress syndrome (0.3%), mesenteric artery thrombosis (0.3%), pneumonia (0.3%), pneumonitis (0.3%), and pulmonary hemorrhage (0.3%)] vs 7.8% with chemotherapy alone.1
  • LIBTAYO was permanently discontinued due to adverse reactions in 5% of patients vs 3% with chemotherapy alone.1
  • Dosage interruptions of LIBTAYO due to an adverse reaction occurred in 33% of patients.1
  • The most common (≥15%) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.1

Per IDMC Recommendations:
EMPOWER-Lung 3 was stopped early due to superior OS.3


Interested in LIBTAYO as a combination therapy?

VIEW EMPOWER-LUNG 3 STUDY DESIGN
In patients with advanced NSCLC who had PD-L1 ≥50% and no EGFR, ALK, or ROS1 aberrations*

LIBTAYO monotherapy vs chemo, ITT (N=710)1

Superior Median OS (ITT): 22.1 months 
(95% CI, 17.7-NE) vs 14.3 months (95% CI, 11.7-19.2) with chemotherapy, HR=0.68, P=0.00221
  • Number of deaths in EMPOWER-Lung 1 (ITT): 30% of patients (108 out of 356 patients) with LIBTAYO and 40% of patients (141 out of 354 patients) with chemotherapy1,4

SAFETY DATA1,4

  • Serious adverse reactions occurred in 28% of patients receiving LIBTAYO
  • The most frequent serious adverse reaction in at least 2% of patients was pneumonia
  • 6% of patients permanently discontinued due to adverse reactions vs 4% with chemotherapy

Per IDMC Recommendations:
EMPOWER-Lung 1 was stopped early due to superior OS.4


Interested in LIBTAYO as a monotherapy?

VIEW EMPOWER-LUNG 1 STUDY DESIGN
  • In EMPOWER-Lung 3, OS was monitored and reviewed per Independent Data Monitoring Committee (IDMC). All secondary analyses were conducted per Blinded Independent Central Review (BICR).
  • In EMPOWER-Lung 1, OS was monitored and reviewed per IDMC; PFS and all secondary analyses were conducted per BICR.
  • *Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.
  • Investigator’s choice: Paclitaxel + cisplatin or carboplatin for squamous NSCLC and pemetrexed + cisplatin or carboplatin for nonsquamous NSCLC. Mandatory pemetrexed maintenance for patients with nonsquamous histology initially assigned a pemetrexed-containing regimen.
  • 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.
  • ALK=anaplastic lymphoma kinase; CI=confidence interval; EGFR=epidermal growth factor receptor; FDA=Food and Drug Administration; HR=hazard ratio; 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