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The PD-L1 stain that decides who can have atezolizumab, scored on immune cells rather than tumour cells in breast cancer.
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 The breast cancer indication for atezolizumab was later withdrawn in the US, but the assay remains in use in Europe and for lung cancer.
Rabbit monoclonal antibody SP142 with OptiView amplification on the BenchMark stainer; scored on tumour cells and on tumour-infiltrating immune cells (IC), the latter being the basis of the breast cancer claim. Connects to PD-L1.
1.VENTANA PD-L1 (SP142) Assay slips into a pocket on PD-L1.
| 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 |
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This is the population-based prevalence for the two label thresholds in early TNBC, and it shows the KEYNOTE-355 CPS 10 gate would admit only about a quarter of unselected patients.
The clearest demonstration that PD-L1 positive in triple-negative breast cancer means different things depending on the kit; with atezolizumab withdrawn, pembrolizumab's 22C3 combined positive score of 10 is the surviving standard, and roughly a quarter of patients get a different answer depending on which assay their laboratory runs.
For the minority of patients whose tumours express a lot of PD-L1, a single antibody outperforms chemotherapy and is far easier to take. The word minority is the point: the same drug in the same disease at lower PD-L1 gives much less.
This is the paper Europe PMC returns for registry id NCT02425891 with the most citations, so it is the natural first reading for anyone following the IMpassion130 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Query 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.
Shares Companion diagnostics, Histopathology & immunohistochemistry, Roche / Genentech, Triple-negative breast cancer (TNBC) and the tag test.
Shares Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry, Roche / Genentech and the tag test.
Shares Companion diagnostics, Roche / Genentech, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC), Non-small-cell lung cancer and the tag test.
Shares Companion diagnostics, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC) and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC) and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC) and the tag test.