VENTANA PD-L1 (SP142) Assay
The PD-L1 stain that decides who can have atezolizumab, scored on immune cells rather than tumour cells in breast cancer.
Overview
Approved 18 May 2016 (PMA P160002) as the first PD-L1 assay linked to atezolizumab, in urothelial carcinoma, and subsequently in non-small-cell lung cancer and, in 2019, as the companion diagnostic for atezolizumab plus nab-paclitaxel in triple-negative breast cancer using an immune-cell threshold of 1% (IMpassion130). SP142 stains fewer tumour cells than 22C3 or SP263, and the Blueprint comparison studies showed it is not interchangeable with them, which is why each drug label names its own assay. The breast cancer indication for atezolizumab was later withdrawn in the US, but the assay remains in use in Europe and for lung cancer.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2016 | PD-L1 expression to inform atezolizumab treatment in urothelial carcinoma (later NSCLC) |
| US | 2019 | Companion diagnostic for atezolizumab in PD-L1 IC ≥1% triple-negative breast cancer |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Notes
top- What a result means: 'PD-L1 positive' on this assay refers to immune cells in the tumour; a different assay with a different cut-off may give a different answer, so ask which test was used.
Latest papers
topQuery for this drug: (TITLE:"VENTANA PD-L1 SP142 Assay" OR ABSTRACT:"VENTANA PD-L1 SP142 Assay" OR TITLE:"VENTANA PD-L1" OR ABSTRACT:"VENTANA PD-L1" OR TITLE:"SP142" OR ABSTRACT:"SP142") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about VENTANA PD-L1 (SP142) Assay, not a curated reading list.
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