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Non-Small-Cell Lung Cancer (NSCLC)
One formalin-fixed paraffin-embedded (FFPE) tissue block or five unstained positively charged slides sectioned from FFPE tissue block at 4 to 5 microns.
Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides
Tissue should be fixed in 10% neutral buffered formalin for no more than 72 hours, embed in paraffin. Alternative fixatives have not been validated and may give erroneous results.
Causes for Rejection
Insufficient tissue; tumor other than nonsquamous non−small-cell lung cancer
Includes technical and professional components
PD-L1 expression is associated with the expanded approval of OPDIVO® (nivolumab) for the treatment of patients with previously-treated non-small cell lung cancer (NSCLC).The DAKO PD-L1 IHC 28-8 pharmDxTM is a complementary diagnostic test to detect PD-L1 protein expression levels, and although not required is a tool that helps physicians determine which patients may benefit most from treatment. In the CheckMate 057 trial PD-L1 expression was associated with improved efficacy across all endpoints (OS, PFS, duration of response) at all expression levels. The most improvement was seen in patients with PD-L1 expression ≥5% and ≥10%, but was evident at PD-L1 expression levels as low as ≥1%. Patients with tumors that had PD-L1 expression levels ≥1% were associated with a doubling of overall median survival.
Nivolumab; 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.