PD-L1 IHC 28-8 pharmDx for Non Small Cell Lung Cancer
PD-L1 IHC 28-8 pharmDx* is now FDA-approved as a companion diagnostic to aid in identifying non-small cell lung cancer (NSCLC) patients for the combo immunotherapy OPDIVO®(nivolumab) plus YERVOY®(ipilimumab).
Demonstrated clinical results
CHECKMATE-227 was a Phase III, randomized, multi-center, multi-cohort, open-label study in patients who had no prior anti cancer therapy with metastatic NSCLC. Part 1a of the study investigated patients with PD-L1 expression level ≥ 1%, who were previously untreated for advanced disease. PD-L1 IHC 28-8 pharmDx was the only test used for PD-L1 expression analysis across all histology in non-squamous and squamous NSCLC.
CHECKMATE-227, Part 1a highlighted the significant survival and response outcomes from combining OPDIVO® (nivolumab) plus
YERVOY® (ipilimumab) as a first line treatment for metastatic NSCLC patients whose tumors exhibited PD-L1 expression ≥ 1%.
* PD-L1 IHC pharmDx is for in vitro diagnostic use.
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
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.
PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial carcinoma (UC) tissues using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.
Companion Diagnostic Indication
PD-L1 Expression Clinical Cut-Off
≥ 1% tumor cell expression
PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).
PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO®.
PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO®.
PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®.
See the OPDIVO® and YERVOY® product labels for specific clinical circumstances guiding PD-L1 testing.