PD-L1 IHC 28-8 pharmDx for Gastric, GEJ, and Esophageal Adenocarcinoma
PD-L1 IHC 28-8 pharmDx is now CE-IVD marked to identify gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal adenocarcinoma patients for the combo immunotherapy OPDIVO (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy
Demonstrated clinical results
It is a phase 3, randomized, multi-center, open-label study in patients with previously untreated, HER2-negative, advanced or metastatic gastric, GEJ, and esophageal adenocarcinoma whose tumors express PD-L1 with a CPS ≥ 5.
The study results highlight overall survival (OS) benefit from OPDIVO (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy.
Refer to the Interpretation Manual to review validated scoring guidelines that can aid in the identification of gastric, GEJ, and esophageal adenocarcinoma patients for treatment with OPDIVO and chemotherapy.
PD-L1 IHC 28-8 pharmDx is CE-IVD marked and fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity and precision.
Selected analytical validation parameters
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
Analytical sensitivity of PD-L1 IHC 28-8 pharmDx was tested on 1226 unique cases of human FFPE specimens (comprised of 439 gastric, 375 GEJ, and 412 esophageal carcinoma, including adenocarcinoma) staged I to IV using a manufactured production lot. Assessment of PD-L1 expression demonstrated staining across a range of CPS 0-100 positive tumor cells and 0-3 staining intensity
Repeatability testing was evaluated for operators/instruments/days using 3 assay lots (95.6 OA) for
PD-L1 expression CPS ≥ 5
Reproducibility testing was evaluated for inter-site assay (94.5 OA), intra-site assay (96.1 OA),
inter-observer (98.8 OA), and intra-observer (99.2 OA) for PD-L1 expression CPS ≥ 5
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 (nsNSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), melanoma, gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal adenocarcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 protein expression in nsNSCLC, SCCHN, UC, and melanoma is determined by using % tumor cell expression, which is the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.
PD-L1 protein expression in gastric adenocarcinoma, GEJ adenocarcinoma, and esophageal adenocarcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Companion Diagnostic Indications
PD-L1 Expression Clinical
Gastric, GEJ, or Esophageal Adenocarcinoma
CPS ≥ 5
PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying gastric, gastroesophageal junction, or esophageal adenocarcinoma patients for treatment with OPDIVO® (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy.
PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC (nsNSCLC) may be associated with enhanced survival from OPDIVO® (nivolumab).
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® (nivolumab).
PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in urothelial carcinoma may be associated with enhanced response rate from OPDIVO®.
PD-L1 expression (≥ 1% or ≥ 5% tumor cell 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.
See the local OPDIVO® and YERVOY® product labels for specific clinical circumstances guiding PD-L1 testing.