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PD-L1 IHC 28-8 pharmDx for Melanoma

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PD-L1 IHC 28-8 pharmDx for melanoma

PD-L1 IHC 28-8 pharmDx is the first fully validated and clinically relevant test for OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) in melanoma.1

Demonstrated clinical results

Data from the CHECKMATE-067 study demonstrated the clinical utility of PD-L1 IHC 28-8 pharmDx to measure PD-L1 expression.

In the CHECKMATE-067 study, a pre-planned retrospective analysis of efficacy based on PD-L1 expression was performed. The overall survival (OS) was evaluated across PD-L1 subgroups in three treatment arms: nivolumab monotherapy, ipilimumab monotherapy, and nivolumab plus ipilimumab combination therapy.1 Results are summarized below.

Summary of overall survival by PD-L1 level and treatment group—all randomized subjects with melanoma—CHECKMATE-0671

PD-L1 expression level nivolumab
Median OS (95% CI)		 ipilimumab
Median OS (95% CI)		 Hazard ratio
(95% CI)a
<1% 23.46 (13.01, NR) 18.56 (13.67, 23.20) 0.80 (0.57, 1.12)
≥1% NR (NR) 22.11 (17.08, 29.67) 0.52 (0.38, 0.71)
PD-L1 expression level nivolumab + ipilimumab
Median OS (95% CI)		 ipilimumab
Median OS (95% CI)		 Hazard ratio
(95% CI)a
<1% NR (26.45, NR) 18.56 (13.67, 23.20) 0.60 (0.42, 0.84)
≥1% NR (NR) 22.11 (17.08, 29.67) 0.53 (0.38, 0.74)
PD-L1 expression level
(Exploratory analysis)		 nivolumab + ipilimumab
Median OS (95% CI)		 nivolumab
Median OS (95% CI)		 Hazard ratio
(95% CI)a
<1% NR (26.45, NR) 23.46 (13.01, NR) 0.74 (0.52, 1.06)
≥1% NR (NR) NR (NR) 1.03 (0.72, 1.48)

a. Hazard ratio for treatment effect based on Cox proportional hazard model with treatment, PD-L1 status, and treatment by PD-L1 status interaction

Abbreviations: CI = confidence interval, NR = not reached, OS = overall survival

An exploratory analysis showed that for patients with melanoma showing <1% expression of PD-L1 on tumor cells, the combination therapy of OPDIVO and YERVOY demonstrated numerically improved OS compared with OPDIVO therapy.

The magnitude of efficacy on OS in combination therapy of OPDIVO plus YERVOY was shown to depend on the proportion of PD-L1 expression on the tumor cells.

Frequency of tumor PD-L1 expression in all randomized subjects with melanoma—CHECKMATE-067

PD-L1 nivolumab nivolumab + ipilimumab ipilimumab Total
No. quantifiable samples* N=288 N=278 N=277 N=843
<1% PD-L1 expression
No. of subjects 117 123 113 353
(%) (40.6) (44.2) (40.8) (41.9)
≥1% PD-L1 expression
No. of subjects 171 155 164 490
(%) (59.4) (55.8) (59.2) (58.1)

*Number of quantifiable PD-L1 results only; indeterminate PD-L1 results not included.

Baseline melanoma specimen origin—CHECKMATE-067

  • 86% of pre-study tumor specimens were collected from melanoma metastatic sites
  • PD-L1 expression status was ascertained for 843 (89%) of the total 945 study patients

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 parameters2		 Results for melanoma
Analytical specificity
  • 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 (0–100% of positive tumor cells, 0–3 staining intensity) exhibited in study of 104 unique cases of melanoma FFPE specimens staged I to IV.
Repeatability
  • >90.0% overall agreement for ≥1% expression level
External reproducibility
  • ≥88.2% overall agreement for ≥1% expression level
  • 95% confidence intervals from 83.8%–97.4% agreement for both ANA and APA

ANA = average negative agreement  |  APA = average positive agreement  |  OA = overall 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 PT100/200

References

  1. Clinical Trial: CHECKMATE-067, CA209067
  2. Data obtained to support US FDA approval and published in the US version of the PD-L1 IHC 28-8 pharmDx Instructions for Use.
  3. PD-L1 IHC 28-8 pharmDx Instructions for Use

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Product information

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

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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), head and neck cancer (HNC), and melanoma 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. Tumor PD-L1 status is defined by indication-specific staining interpretation.

To measure the proportion of PD-L1 expression in cancer tissue or cells.

  • Indicated as an aid for proper administration of nivolumab [recombinant] in non-squamous non-small cell lung cancer [NSCLC] patients and head and neck cancer (HNC) patients.
  • Indicated as an aid for proper administration of nivolumab and ipilimumab combination in melanoma patients.3