PD-L1 IHC 28-8 pharmDx for SCCHN

The only CE-IVD test for PD-L1 expression associated with enhanced survival with OPDIVO^® (nivolumab) for SCCHN¹

Demonstrated clinical results

PD-L1 IHC 28-8 pharmDx is the first fully validated and clinically relevant test for OPDIVO in SCCHN.

Detection of PD-L1 expressing tumor cells in SCCHN patient specimens may indicate an enhanced survival benefit to OPDIVO (nivolumab) treatment for the patient.²

The CA209141 study demonstrated a statistically significant improvement in overall survival (OS) for subjects randomized to nivolumab as compared to investigator’s choice at a pre‑specified interim analysis (78% of the planned number of events for final analysis). The median OS was 7.5 months for nivolumab subjects compared to 5.1 months for investigator’s choice subjects with a hazard ratio (HR) of 0.70 (95% CI 0.53, 0.92).

Summary of OS by PD-L1 IHC 28-8 pharmDx expression level and treatment group¹

Data from a pre-specified exploratory analysis (N=260) of CA209141 (N=361).

PD-L1 Expression	<1%		≥1%
	Nivolumab	Investigator’s Choice	Nivolumab	Investigator’s Choice
Median OS (95% CI)	5.7 mos. (4.4‑12.7)	5.8 mos. (4.0‑9.8)	8.7 mos. (5.7‑9.1)	4.6 mos. (3.8‑5.8)
Hazard Ratios	0.89 (95% CI: 0.54, 1.45)		0.55 (95% CI: 0.36, 0.83)
Abbreviations: CI = confidence interval

361 patients were randomized at 55 sites in 15 countries to one of two treatment arms (240 nivolumab vs. 121 to investigator’s choice) and stratified according to prior cetuximab treatment (yes/no). The major efficacy outcome measure for CA209141 was Overall Survival (OS). Additional efficacy outcome measures included Progression Free Survival (PFS) and Objective Response Rate (ORR).

Frequency of PD-L1 Expression in Quantifiable* Samples from SCCHN—CA209141¹

PD-L1 Expression	Nivolumab (N=161)	Investigator’s Choice (N=99)	Total (N=260)
≥1% PD-L1 Expression Subjects	88 (54.7%)	61 (61.6%)	149 (57.3%)
<1% PD-L1 Expression Subjects	73 (45.3%)	38 (38.4%)	111 (42.7%)
*327 of 361 samples were PD-L1 quantifiable from study CA209141.

Baseline SCCHN Specimen Origin—Study CA209141¹

Tumor specimens were collected from SCCHN tumors from either a primary or metastatic site, consistent with the inclusion requirements for the study. 327 subjects (out of 361 total subjects) had tumor tissue collected at baseline with the following site proportion:

Primary Tumor

29.7%
(97/327)

Metastatic Tumor

52.0%
(170/327)

Not reported

18.3%
(60/327)

Robust performance

PD-L1 IHC 28-8 pharmDx is fully validated for analytical performance, having met stringent acceptance criteria for ultimate quality results.

Selected analytical validation parameters	Results for SCCHN
Analytical specificity	Demonstrated specificity to clone 28-8 for PD-L1 detection PD-L1 primary antibody displays no cross-reactivity for PD-L2 Detection in normal tissues restricted to immune cells and infrequently to cells of epithelial origin
Sensitivity	Broad dynamic range of PD-L1 expression (0-95% of positive tumor cells, 0-3 staining intensity) exhibited in study of 236 unique cases of SCCHN FFPE specimen stages I to IV
Repeatability	Demonstrated lot-to-lot repeatability 100% overall agreement for ≥1% expression level
External reproducibility	≥97% overall agreement for ≥1% expression level Reproducibility testing of day-to-day, site-to-site and observer-to-observer in a blinded study in three certified clinical labs 95% confidence intervals from 88% to 100% agreement for both NPA and PPA
NPA = Negative Percent Agreement \| PPA = Positive Percent Agreement

Order information

Product	Code
PD-L1 IHC 28-8 pharmDx	SK005
Required but not included in kit:
Autostainer Link 48	AS480
EnVision FLEX Wash Buffer, 20x	K8007
EnVision FLEX Hematoxylin (Link)	K8008
PT Link	PT101/PT200

References

Clinical Trial: Checkmate 141, CA209141
PD-L1 IHC 28-8 pharmDx Instructions for Use

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Product Information

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

PD-L1 IHC 28-8 pharmDx

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-squamous non small cell lung cancer (NSCLC) and melanoma tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity.

PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC and SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab) treatment.

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.