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).
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)
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
Investigator’s Choice (N=99)
≥1% PD-L1 Expression Subjects
<1% PD-L1 Expression Subjects
*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:
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
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
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
Demonstrated lot-to-lot repeatability
100% overall agreement for ≥1% expression level
≥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
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.