Non-Small-Cell Lung Cancer (NSCLC)
Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides
At least three unstained slides sectioned at 4 to 5 microns. Five slides are ideal.
Paraffin block or unstained slides. Send slides within 6 months of sectioning.
Causes for Rejection
Insufficient tissue; inappropriate tissue source; incorrect specimen type
Maintain specimen at room temperature
Includes technical and professional components
Non-Small Cell Lung Cancer (NSCLC)
PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS ≥ 1% and high PDL1 expression if TPS ≥ 50%.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab).
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
PD-L1 protein expression in gastric or GEJ adenocarcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The specimen should be considered to have PD-L1 expression if CPS ≥ 1.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).
Pembrolizumab; Programmed Death Ligand 1
- Kim, JW and Eder, JP, Prospects for Targeting PD-1 and PD-L1 in Various Tumor Types. Available on the website of the Cancer Network. (http://www.cancernetwork.com/oncology-journal/prospects-targeting-pd-1-and-pd-l1-various-tumor-types). Accessed July 8, 2015.
- Garon, EB et al., Pembrolizumab for the Treatment of Non-Small-Cell Lung Cancer. N Engl J Med 2015; 372:2018-28.