PD-L1 IHC 28-8 pharmDx for Non Small Cell Lung Cancer

More personalized cancer results. One test makes it possible.

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 28-8 pharmDx NSCLC Interpretation Manual

Refer to the NSCLC Interpretation Manual to review validated scoring guidelines that can aid in the identification of NSCLC patients for treatment with OPDIVO^® and YERVOY^®.

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PD-L1 IHC 28-8 pharmDx NSCLC Interpretation Training Program

Get the training that may help you accurately evaluate and score PD?L1 expression in patients with NSCLC

PD-L1 IHC 28-8 pharmDx NSCLC Brochure

PD-L1 IHC 28-8 pharmDx has been analytically validated for specificity, sensitivity, and reproducibility, and shows high clinical utility across various indications.

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Product details, specification sheet and safety data sheet (SDS).

PD-L1 IHC 28-8 pharmDx

* PD-L1 IHC pharmDx is for in vitro diagnostic use.

Robust performance

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	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.
Sensitivity	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	Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance. ≥ 98.1% OA for ≥ 1% expression level.
Reproducibility	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.

OA = Overall Agreement

Order information

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 PT Link Rinse Station	AS480 K8007 K8008 PT101 / PT200 PT109

References

CHECKMATE-227. M.D. Hellmann, et al. Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer, The New England Journal of Medicine, 2019.
PD-L1 IHC 28-8 pharmDx Instructions for Use.
YERVOY^® package insert. Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA U.S. License No. 1713.
OPDIVO^® package insert. Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA U.S. License No. 1713.

PD-L1 IHC 28-8 NSCLC pharmDx Intended Use

Intended use

Intended Use

For in vitro diagnostic use. 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

Tumor Indication	PD-L1 Expression Clinical Cut-Off	Intended Use
NSCLC	≥ 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.

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