NOW APPROVED
AS A FIRST-LINE TREATMENT OPTION IN
ADVANCED NSCLC

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

Learn more about LIBTAYO as a first-line monotherapy in advanced NSCLC.

Learn more about the data

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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 kinas.

LIBTAYO safety profile in EMPOWER-Lung 11

Adverse reactions in ≥10% of patients1

safety profile
  • *Musculoskeletal pain is a composite term that includes back pain, arthralgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, bone pain, myalgia, neck pain, spinal pain, and musculoskeletal stiffness.
  • Rash is a composite term that includes rash, dermatitis, urticaria, rash maculopapular, erythema, rash erythematous, rash pruritic, psoriasis, autoimmune dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, drug eruption, dyshidrotic eczema, lichen planus, and skin reaction.
  • Fatigue is a composite term that includes fatigue, asthenia, and malaise.
  • §Pneumonia is a composite term that includes atypical pneumonia, embolic pneumonia, lower respiratory tract infection, lung abscess, paracancerous pneumonia, pneumonia, pneumonia bacterial, and pneumonia klebsiella.
  • §Cough is a composite term that includes cough and productive cough.
  • Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

  • LIBTAYO was permanently discontinued due to adverse reactions in 6% of patients1;
  • Adverse events resulting in permanent discontinuation in at least 2 patients were pneumonitis, pnuemonia, ischemic stroke, and increased aspartate aminotransferase1
  • Serious adverse reactions occurred in 28% of patients receiving LIBTAYO1;
  • The most frequent serious adverse event in at least 2% of patients were pneumonia and pneumonitis1

In patients who had no EGFR, ALK, or ROS1 aberrations:

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


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)

Primary endpoints1:
  • OS and PFS
Secondary endpoints included1,2:
  • ORR (key), DOR, and safety and tolerability

LIBTAYO was examined in a clinical study that included historically underrepresented patients with advanced NSCLC1,2:

In the LIBTAYO arm (ITT patient population) at baseline, 12% of patients had pretreated and stable brain metastases,* 18% had locally advanced disease, and 2% had controlled hepatitis B or hepatitis C. Patients with HIV were permitted to enroll, but none were recruited.1,2,4
  • *Patients were eligible if they had been adequately treated and had neurologically returned to baseline for at least 2 weeks prior to randomization.1
  • 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
  • Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on therapy with LIBTAYO were permitted to continue treatment with LIBTAYO 350 mg Q3W for up to 108 additional weeks, along with the addition of histology-specific chemotherapy for 4 cycles until further disease progression was observed.1
  • §Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on chemotherapy were permitted to receive treatment with LIBTAYO for up to 108 weeks.1,2
  • Randomization was stratified by histology (nonsquamous vs squamous) and geographic region (Europe vs Asia vs rest of world).1
  • Median duration of exposure was 27.3 weeks (range, 9 days-115 weeks) for LIBTAYO vs 17.7 weeks (range, 18 days-86.7 weeks) for chemotherapy.1
  • DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; IRC=independent review committee; IV=intravenous; ORR=objective response rate; PD=progressive disease; PFS=progression free survival; PS=performance status; Q3W=every 3 weeks; R=randomization; RECIST=Response Evaluation Criteria in Solid Tumors.

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: https://www.sciencedirect.com/science/article/abs/pii/S0140673621002282. Accessed February 13, 2021. 3. PD-L1 IHC 22C3 pharmDx [instructions for use]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021. 4. Data on file. Regeneron Pharmaceuticals, Inc.