Importance of Testing for PD-L1 Expression in NSCLC

In patients with mNSCLC, PD-L1 expression level may predict response to anti–PD-1/PD-L1 therapy and guide treatment decisions.1-5

In patients with mNSCLC, PD-L1 expression level may predict response to anti–PD-1/PD-L1 therapy and guide treatment decisions.1-5

  • Diagnostic assays can detect PD-L1 expression levels to help determine a patient’s eligibility for anti–PD-1/PD-L1 therapy1-5
  • PD-L1 expression is measured across a continuum and scoring cutoffs vary by assay6-8

Available assays for PD-L1 testing in NSCLC6-8

  Ventana
PD-L1 (SP263)
Ventana
PD-L1 (SP142)
Dako PD-L1 IHC 22C3 pharmDx Dako PD-L1 IHC 28-8 pharmDx
  • Definition of positive
TC ≥25% 

TC ≥50%

OR

IC ≥10% 

TC ≥1%

(low expression)

TC ≥50%

(high expression)

TC ≥1%
  • Definition of positive
  • Ventana PD-L1 (SP263)
  • TC ≥25% 
  • Ventana PD-L1 (SP142)
  • TC ≥50% OR IC ≥10%
  • Dako PD-L1 IHC 22C3 pharmDx
  • TC ≥1% (low expression)
  • TC ≥50% (high expression)
  • Dako PD-L1 IHC 22C3 pharmDx
  • TC ≥1%

PD-L1 expression in a biopsy sample may range from <1% to 100%9,*

PD-L1 expression in a biopsy sample may range from <1% to 100%9,*

Range of PD-L1 expression in non-small cell lung cancer (NSCLC)
Range of PD-L1 expression in non-small cell lung cancer (NSCLC)

*IHC staining and scoring of PD-L1 expression in NSCLC tumor tissue using the PD-L1 IHC 22C3 pharmDx assay.9

In newly diagnosed patients with mNSCLC,
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend testing for PD-L1 expression.10

In newly diagnosed patients with mNSCLC, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend testing for PD-L1 expression.10

ALK, anaplastic lymphoma kinase; BRAF, v-Raf murine sarcoma viral oncogene homolog B; EGFR, epidermal growth factor receptor; IC, immune cell; IHC, immunohistochemistry; mNSCLC, metastatic non–small cell lung cancer; NCCN, National Comprehensive Cancer Network; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; ROS1, ROS proto-oncogene 1, receptor tyrosine kinase; TC, tumor cell; TPS, tumor proportion score.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References: 1. Borghaei H et al. N Engl J Med. 2015;373(17):1627-1639. 2. Garon EB et al. N Engl J Med. 2015;372(21):2018-2028. 3. Herbst RS et al. Nature. 2014;515(7528):563-567. 4. Herbst RS et al. Lancet. 2016;387(10027):1540-1550. 5. Fehrenbacher L et al; POPLAR Study Group. Lancet. 2016;387(10030):1837-1846. 6. Ventana PD-L1 (SP142) Assay [package insert]. Tucson, AZ: Ventana Medical Systems, Inc.; 2018. 7. Dako PD-L1 IHC 22C3 pharmDx [interpretation manual]. Santa Clara, CA: Agilent Technologies; 2016. 8. Dako PD-L1 IHC 28-8 pharmDx [interpretation manual]. Santa Clara, CA; Agilent Technologies; 2015. 9. Sorensen SF et al. Transl Oncol. 2016;9(1):64-69. 10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V6.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed September 27, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org.