Predictive IHC assay
VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:
VENTANA PD-L1 (SP263) Assay expands immunotherapy options for NSCLC patients through equipping pathologists by:
**Based on a method comparison study carried out by AstraZeneca, which compares data from currently available PD-L1 assays, PD-L1 IHC 22C3 pharmDx (used in the clinical studies of KEYTRUDA), PD-L1 IHC 28-8 pharmDx (used in the clinical studies of OPDIVO) and VENTANA PD-L1 (SP263) Assay.
†IC staining with this assay is not used to assess PD-L1 status for KEYTRUDA or OPDIVO in NSCLC.
The VENTANA PD-L1 (SP263) Assay is the clinical trial enrollment assay for IMFINZITM (durvalumab) and the only PD-L1 assay validated to assess UC patient treatment benefit from this PD-L1 inhibitor. Using a validated assay to determine PD-L1 status for immunotherapies is important. VENTANA PD-L1 (SP263) Assay equips pathologists by:
Indication for use |
Therapy |
PD-L1 Expression-Therapeutic Line |
|
NSCLC |
KEYTRUDA |
≥50% TC – First Line |
|
≥1% TC – Second Line |
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OPDIVO |
≥1%, ≥5% and ≥10% TC – Second Line |
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UC |
IMFINZI |
PD-L1 status is considered High if any of the following are met: |
VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), urothelial carcinoma (UC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.
NSCLC:
PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with KEYTRUDA® (pembrolizumab).
PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab).
Urothelial Carcinoma:
PD-L1 High status as determined by VENTANA PD-L1 (SP263) Assay was associated with increased objective response rate (ORR) in a single arm study of IMFINZI™ (durvalumab). PD-L1 status is determined by the percentage of tumor cells with any membrane staining above background or by the percentage of tumor-associated immune cells with staining (IC+) at any intensity above background. The percent of tumor area occupied by any tumor-associated immune cells (Immune Cells Present, ICP) is used to determine IC+, which is the percent area of ICP exhibiting PD-L1 positive immune cell staining.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
This product is intended for in vitro diagnostic (IVD) use.
The assay is intended for identifying patients who may benefit from therapy as shown in Table 1.