PD-L1 IHC 28-8 pharmDx for non-squamous NSCLC

The only FDA-approved test for PD-L1 expression associated with enhanced survival with OPDIVO? (nivolumab) for non-squamous NSCLC. PD-L1 IHC 28-8 pharmDx is a complementary diagnostic for PD-L1 expression in non-squamous NSCLC. Patients with PD-L1 expression by all predefined expression levels in the OPDIVO group were associated with enhanced survival compared to docetaxel.

≥ 1% PD-L1 expression → 41% Reduction in Risk of Death (HR = 0.59) 17.1 months median OS vs. 9 months for docetaxel

≥ 5% PD-L1 expression → 57% Reduction in Risk of Death (HR = 0.43) 18.2 months median OS vs. 8.1 months for docetaxel

≥ 10% PD-L1 expression → 60% Reduction in Risk of Death (HR = 0.40) 19.4 months median OS vs. 8 months for docetaxel

PD-L1 testing is not required for the use of OPDIVO, but it will provide additional information for physicians and inform patient dialogue. In patients with no PD-L1 expression (< 1%), survival with OPDIVO was similar to docetaxel. Dako PD-L1 IHC 28-8 pharmDx is FDA approved and fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity and precision.

Selected analytical validation parameters	Description
Specificity	Primary antibody: rabbit monoclonal, clone 28-8 Detects PD-L1 on the plasma membranes of tumor cells, the staining of which can be completely abolished by PD-L1 gene knock-out Detection in normal tissues is restricted to immune cells and infrequently the cells of epithelial origin Clone 28-8 exhibits no cross reactivity to PD-L2
Sensitivity	Broad dynamic range of PD-L1 expression (0-100% tumor cells positive, 0-3 staining intensity) exhibited in study of 112 unique cases of non-squamous NSCLC archival FFPE specimens In BMS clinical study CA209057 of patients with non-squamous NSCLC, approximately 54% and 40% had PD-L1 expression levels ≥1% and ≥5%, respectively
Repeatability	Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance ≥ 99% overall agreement for ≥ 1%, ≥ 5% and ≥ 10% expression levels 95% confidence intervals ranged from 82.4 to 100% for NPA, PPA, and OA*
Reproducibility	Reproducibility testing of day-to-day, site-to-site and observer-to-observer performance in a blinded study in three certified clinical labs ≥ 94% overall agreement for ≥ 1% and ≥ 5% expression levels 95% confidence intervals ranged from 78.5 to 100% for NPA, PPA, and OA

* Negative Percent Agreement, Positive Percent Agreement, Overall Percent Agreement

Reference 2) Phillips T, Simmons P, Inzunza H, Cogswell J, Novotny J, Taylor C, Zhang X. Development of an automated PD-L1 immunohistochemistry (IHC) assay for non.small cell lung cancer. Appl Immunohistochem Mol Morph 2015;8:541-9.

Product	Code
PD-L1 IHC 28-8 pharmDx	SK005
Required but not included in kit: Autostainer Link 48 EnVision FLEX Wash Buffer, 20x EnVision FLEX Hematoxylin (Link) PT Link	AS480 K8007 K8008 PT100