PD-L1 IHC 28-8 pharmDx for melanoma

The first and only CE-IVD marked PD-L1 test for use in the assessment of patients for whom OPDIVO® (nivolumab) and YERVOY® (ipilimumab) combination treatment is being considered in melanoma.¹

PD-L1 IHC 28-8 pharmDx demonstrated clinical results in the phase 3 CheckMate-067 clinical trial.

The CheckMate -067 study was a three armed study of OPDIVO® (nivolumab) monotherapy or OPDIVO in combination with YERVOY® (ipilimumab) versus YERVOY monotherapy

Progression free survival was evaluated across PD-L1 subgroups.

PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in melanoma may be used as an aid in the assessment of patients for whom OPDIVO (nivolumab) and YERVOY (ipilimumab) combination treatment is being considered.

PD-L1 IHC 28-8 pharmDx is CE-IVD marked and fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity, repeatability, and reproducibility.¹

Selected analytical validation parameters	Results for metastatic melanoma
Analytical 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 3 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 104 unique cases of melanoma archival FFPE specimens In BMS clinical study CheckMate CA209067 of patients with melanoma, approximately 58% had PD-L1 expression levels ≥1% and approximately 28% had PD-L1 expression levels ≥5%
Repeatability	Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance ≥ 90% overall agreement for ≥1% expression level 95% confidence intervals ranged from 83.2 to 99.4% in ≥1% and 77,6 to 96,4 in ≥5% for ANA, APA, and OA*
External Reproducibility	Reproducibility testing day-to-day, site-to-site and observer-to-observer performance in a blinded study in three certified clinical labs ≥ 90% overall agreement for ≥1% expression level 95% confidence intervals ranged from 88.1 to 100% for ANA, APA, and OA*

*Average Negative Agreement, Average Positive Agreement, and Overall Agreement

Product	Code
PD-L1 IHC 28-8 pharmDx	SK005
Required but not included in kit: EnVision FLEX Wash Buffer, 20x EnVision FLEX Hematoxylin (Link) PT Link	AS480 K8007 K8008 PT101

1. PD-L1 IHC 28-8 pharmDx Instruction For Use

2. Clinical Trial: Checkmate 067, CA209067

3. 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