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PD-L1 IHC 28-8 pharmDx for Urothelial Carcinoma

More personalized cancer results. One test makes it possible.

PD-L1 IHC 28-8 pharmDx for UC

The only FDA-approved test for which PD-L1 expression in urothelial carcinoma may be associated with enhanced response rate from OPDIVO® (nivolumab)1

Demonstrated clinical results

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

In study CHECKMATE-275, objective response rate (ORR) based on PD-L1 expression was evaluated using PD-L1 IHC 28-8 pharmDx and is summarized below. Median time to response was 1.9 months (range; 1.6-7.2).

Efficacy results for study CHECKMATE-2751

Confirmed ORR in all patients and the two PD-L1 subgroups are summarized in the table below.

Tumor PD-L1 Expression <1% ≥1% All Treated Subjects
Total No. of Subjects N=146 N=124 N=270
Confirmed Objective Response Rate
No. of Subjects
(95% CI)		 22
(9.7, 21.9)		 31
(17.7, 33.6)		 53
(15.1, 24.9)
Complete Response Rate
No. of Subjects
(% of Total in PD-L1 expression category)		 1
(0.7%)		 6
(4.8%)		 7
(2.6%)
Partial Response Rate
No. of Subjects
(% of Total in PD-L1 expression category)		 21
(14.4%)		 25
(20.2%)		 46
(17.0%)
Median Duration of Response*
Months (range)		 7.6 mos.
(3.7+, 12.0+)		 NE
(1.9+, 12.0+)		 10.3
(1.9+, 12.0+)

*Estimated from the Kaplan-Meier Curve

Clinical utility of PD-L1 IHC 28-8 pharmDx was evaluated in CHECKMATE-275, a phase II single arm clinical trial of nivolumab in subjects with metastatic or unresectable urothelial carcinoma or who have progressed or recurred following treatment with a platinum agent. 270 subjects were randomized to receive the drug at 63 sites in 11 countries. Major efficacy outcome measures included confirmed objective response rate (ORR) and duration of response (DOR).

Frequency of PD-L1 expression in samples from UC - CHECKMATE-2751

Tumor PD-L1 Expression Nivolumab (N=270)
≥1% PD-L1 Expression Subjects 124 (45.9%)
<1% PD-L1 Expression Subjects 146 (54.1%)

Baseline UC specimen origin - CHECKMATE-2751

Non-bladder UC

27%
(73/270)

Visceral metastases

84%
(227/270)
  • 27% of nivolumab treated patients had non-bladder urothelial carcinoma
  • Regardless of tumor site, 84% of all treated patients presented with visceral metastases at baseline

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 UC
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 138 unique cases of human urothelial carcinoma FFPE specimen stages III to IV
Repeatability
  • Demonstrated lot-to-lot repeatability
  • >91.9% overall agreement for ≥1% expression level
External reproducibility
  • ≥87.0% 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 77.7% to 98.2% 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 PT101/PT200
PT Link rinse station PT109

References

  1. Clinical Trial: CHECKMATE-275, CA209275
  2. 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), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), 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.