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The TC score is the percentage of tumour cells staining for PD-L1 on the SP263 or 28-8 assays. Atezolizumab uses 1 percent after lung surgery and 50 percent for first-line treatment alone; nivolumab with ipilimumab uses 1 percent in first-line lung cancer.
Tumour-cell scoring on the VENTANA SP263 and Dako 28-8 assays is arithmetically the same as TPS (percentage of tumour cells with membrane staining) but is tied to different drugs and assays, so labels write it as TC or as 'PD-L1 expression on >= 1% of tumor cells'. Atezolizumab's adjuvant NSCLC indication after resection and platinum chemotherapy requires PD-L1 on >= 1 percent of tumour cells (IMpower010, SP263), and its first-line single-agent indication uses TC >= 50 percent (or IC >= 10 percent). Nivolumab with ipilimumab in first-line metastatic NSCLC is approved for tumours expressing PD-L1 >= 1 percent on the 28-8 pharmDx (CheckMate 227). Blueprint phase 2 found SP263, 22C3 and 28-8 closely concordant for tumour-cell scoring, which is why the FDA has accepted each as a companion for several antibodies.
In plain words · PD-L1 is the tumour's side of the PD-1 brake, and also the biomarker that decides who gets immunotherapy.
A TC percentage is the share of tumour cells that stain. After lung cancer surgery, 1 percent or more is the label threshold for a year of atezolizumab; in metastatic lung cancer 50 percent or more allows atezolizumab on its own, and 1 percent or more allows nivolumab with ipilimumab. Ask which assay was used, because the drug the result applies to follows the assay.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
Percentage of tumour cells with membrane staining of any intensity on the SP263 or 28-8 assay; immune cells are not counted.
“PD-L1 protein expression (PD-L1 stained ≥ 1% of tumor cells [TC ≥ 1%])”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| PD-L1 on >= 1% of tumour cells (adjuvant) | Atezolizumab | Non-small-cell lung cancer | FDA | label |
| TC >= 50% (or IC >= 10%) | Atezolizumab | Non-small-cell lung cancer | FDA | label |
| PD-L1 >= 1% tumour cells (28-8 pharmDx) FDA companion diagnostic row P150025/S013 (15 May 2020) for Opdivo in combination with Yervoy in NSCLC. | Nivolumab | Non-small-cell lung cancer | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| Ventana PD-L1 (SP263) Assay | Ventana Medical Systems (Roche) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Atezolizumab | P160046/S010 (10/15/2021) |
| PD-L1 IHC 28-8 pharmDx | Agilent Technologies (Dako) | Non-small cell lung cancer (NSCLC) - Tissue | NivolumabIpilimumab | P150025/S013 (05/15/2020) |
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 NCT02477826 with the most citations, so it is the natural first reading for anyone following the CheckMate 227 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.
It is the reason a laboratory can run one stain and report against several drug labels, and the reason any decision resting on an immune-cell score rests on the least reproducible number in lung pathology.
Together with the Blueprint work it establishes that a PD-L1 percentage reports the assay as much as it reports the tumour, so the threshold and the antibody have to be quoted together.
Read beside the pembrolizumab trial that succeeded at a 50% threshold in the same setting, it is the cleanest demonstration that a PD-L1 threshold is not a property of the protein but of the trial that drew the line.
Two bottleneck pages on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
Shares CheckMate 026: first-line nivolumab in stage IV or recurrent non-small-cell lung cancer, Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden, Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC, Non-small-cell lung cancer and the tag biomarker.
Shares PD-L1 CPS (combined positive score), Immunohistochemistry (IHC) and the tag biomarker.
Shares VENTANA PD-L1 (SP263) Assay, PD-L1 IC score (immune-cell score, SP142), Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC, PD-L1 expression testing (22C3, SP142, SP263).
Shares Immunohistochemistry (IHC), Non-small-cell lung cancer and the tag biomarker.
Shares PD-L1 TPS (tumour proportion score), Non-small-cell lung cancer and the tag biomarker.
Shares PD-L1 CPS (combined positive score) and the tag biomarker.
Shares Immunohistochemistry (IHC), Ipilimumab, Nivolumab and the tag biomarker.
Shares Immunohistochemistry (IHC) and the tag biomarker.