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PD-L1 IHC 28-8 pharmDx® is now MHLW-approved as an aid in identifying Gastric cancer patients for the combo immunotherapy OPDIVO® (nivolumab) plus fluoropyrimidine and platinum-containing chemotherapy
Demonstrated clinical results
CHECKMATE-649 is a Phase 3, randomized, multi-center, open-label study in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric cancer whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.
CHECKMATE-649 results highlight overall survival (OS) benefit from OPDIVO® (nivolumab) in combination with fluoropyrimidine and
platinum-containing chemotherapy in non-HER2-positive patients whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.
PD-L1 IHC 28-8 pharmDx Gastric cancer Interpretation Manual
Refer to the gastric cancer Interpretation Manual to review validated scoring guidelines that can aid in the identification of gastric cancer patients for treatment with OPDIVO® and Chemotherapy.
PD-L1 IHC 28-8 pharmDx is MHLW-approved and fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity and precision.
Selected analytical validation parameters
Demonstrated specificity to clone 28-8 for PD-L1 detection.
Detection in normal tissues is restricted to immune cells and infrequently the cells of epithelial origin.
PD-L1 primary antibody displays no cross-reactivity for PD-L2.
Analytical sensitivity of PD-L1 IHC 28-8 pharmDx was tested on 186 unique cases of human NSCLC FFPE specimens staged I to IV using a manufactured production lot. Assessment of PD-L1 expression demonstrated staining across a range of 0–100% positive tumor cells and 0–3 staining intensity.
Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance.
≥ 98.1% OA for ≥ 1% expression level.
Reproducibility testing of inter-site assay, intra-site assay, inter-observer and intra-observer.
97.9% is a point estimate OA for ≥ 1% expression level.