VENTANA PD-L1 (SP263) Assay (CE IVD)

Predictive IHC assay

Guiding immunotherapy decisions

VENTANA PD-L1 predictive assays identify patients who are most likely to respond to specific therapies, generating results you can trust so that you can make timely diagnostic decisions and therapeutic choices. We support your expertise by providing you with the tools that you need to successfully implement these assays into your laboratory and interpret them proficiently.

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Empowering pathologists to answer PD-L1 questions

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

Identifying NSCLC patients eligible for treatment with IMFINZI^TM(durvalumab)
Non-small cell lung cancer (NSCLC) patients eligible for treatment with KEYTRUDA^®(pembrolizumab)
Non-squamous NSCLC patients most likely to benefit from OPDIVO^® (nivolumab)
Urothelial carcinoma (UC) patients most likely to benefit from IMFINZI^TM (durvalumab)

Non-small cell lung cancer (NSCLC)

VENTANA PD-L1 (SP263) Assay expands immunotherapy options for NSCLC patients through equipping pathologists by:

Identifying NSCLC patients eligible for treatment with IMFINZI (durvalumab)
Identifying NSCLC patients eligible for treatment with KEYTRUDA (pembrolizumab)**
Identifying non-squamous NSCLC patients most likely to benefit from OPDIVO (nivolumab)**
Providing robust PD-L1 staining in both tumor cells (TC) and tumor-infiltrating immune cells (IC)^†
Allowing optimal lung tissue management through PD-L1 testing of archived unstained slides within 12 months

**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.

Urothelial carcinoma

The VENTANA PD-L1 (SP263) Assay is the clinical trial enrollment assay for IMFINZI (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:

Identifying urothelial carcinoma patients most likely to benefit from IMFINZI (durvalumab)
Producing robust PD-L1 staining in both tumor cells (TC) and tumor-infiltrating immune cells (IC)
Providing access to multiple immunotherapy options for different cancer types.

Related information

Online training for pathologists

The PD-L1 immunologic checkpoint

The tumor microenvironment

About PD-L1: Rewriting the book on immunotherapy

Learn more about Personalized Healthcare (PHC)

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) 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 IMFINZI™ (durvalumab).

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. Please refer to the respective drug labeling for clinical recommendations pertaining to PD-L1 expression.

Table 1. Therapy and associated indication.

View Full Table

Indication for use	Therapy	PD-L1 Expression-Therapeutic Line
NSCLC	IMFINZI™	≥ 1% TC –Post chemoradiation therapy (CRT)

	KEYTRUDA®	≥50% TC – First Line
		≥1% TC – Second Line
	OPDIVO®	≥1%, ≥5% and ≥10% TC – Second Line
UC	IMFINZI™	PD-L1 status is considered High if any of the following are met: • ≥25% TC membrane staining; or, • ICP > 1% and IC+ ≥ 25%; or, • ICP = 1% and IC+ = 100%. – Second Line