Advanced NSCLC Monotherapy Treatment


Hypothetical patients based on those studied in EMPOWER-Lung 1

Case discussion: Squamous Stage IV NSCLC with pulmonary metastases and
PD-L1 expression of 95%

No EGFR, ALK, or ROS1 aberrations

Meet Peter, 68 years old

Advanced NSCLC Hypothetical Patient Portrayal Peter
Hypothetical patient profile

Reasons for visit

  • Persistent cough lasting ~3 months

Medical history

  • Poorly controlled hypertension and well-controlled hepatitis B
  • ECOG PS 0
  • Former smoker (40 pack-years); quit 5 years ago
  • Treatment-naive

Social support

  • Lives near his son

Clinical information: Imaging and staging

Tumor locations

Tumor locations demonstrated on skeletal X-ray Tumor locations demonstrated on skeletal X-ray
  • Ipsilateral mediastinal lymph node involvement
  • Small (≤1.5 cm) bilateral pulmonary metastases in all lobes
  • Primary tumor: 4.2-cm mass in the right-lower lobe, which invaded the lobar bronchus
  • For illustrative purposes only.

  • Chest X-ray revealed an opacity in the right-lower lung
  • Follow-up CT scans confirmed the presence of a 4.2-cm diameter mass in the lower lobe of the patient's right lung, small bilateral pulmonary nodules in all lung lobes, and ipsilateral mediastinal lymph node involvement
  • PET-CT scan revealed FDG avidity in all lesions
  • MRI revealed no brain metastases
  • Stage IVA
  • TNM staging was T4N2M1a
Compound microscope

Clinical information:

  • Biopsy of the right-lower lobe mass confirmed poorly differentiated squamous cell carcinoma (TTF-1 negative, p40 positive)
  • Biopsy of contralateral lung nodule confirmed metastatic squamous cell carcinoma
  • Plasma and tissue NGS were unremarkable for actionable driver mutations, including EGFR, ALK, and ROS1
  • PD-L1 expression by IHC 22C3 pharmDx assay was 95%

Patient has high PD-L1 expression and well-controlled hepatitis B

  • ALK=anaplastic lymphoma kinase; CT=computed tomography; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; FDG=fluorodeoxglucose; IHC=immunohistochemistry; MRI=magnetic resonance imaging; NGS=next generation sequencing; PD-L1=programmed death ligand 1; PET=positron emission tomography; ROS1=ROS proto-oncogene 1, receptor tyrosine kinase; TTF-1=thyroid transcription factor-1.

Based on this clinical information, Peter is a potential candidate for LIBTAYO monotherapy.

Review the data from EMPOWER-Lung 1 to help you understand how LIBTAYO may be appropriate for patients like Peter.

See EMPOWER-LUNG 1 Study Design