# PD-L1 CPS (combined positive score)

Source: https://onco.cc/biomarkers/pd-l1-cps/  
OnCo record `pd-l1-cps` (Biomarker). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CPS counts every PD-L1-stained cell in the tumour, immune cells included, and divides by the number of tumour cells. Pembrolizumab labels use CPS 1 or CPS 10 as the gate in head and neck, stomach, oesophageal, cervical, ovarian and triple-negative breast cancer.

## Summary

The combined positive score is the 22C3 pharmDx read used outside lung cancer: the number of PD-L1-staining cells (tumour cells, lymphocytes and macrophages) divided by the total number of viable tumour cells, multiplied by 100, so it can exceed 100 in principle and is reported as a whole number. Pembrolizumab's US label gates first-line head and neck cancer, HER2-negative and HER2-positive gastric or GEJ adenocarcinoma, first-line oesophageal cancer with chemotherapy, cervical cancer and platinum-resistant ovarian cancer at CPS >= 1, and triple-negative breast cancer and second-line oesophageal squamous cancer at CPS >= 10. Nivolumab's label now restricts its gastric, GEJ and oesophageal indications to tumours expressing PD-L1 (>= 1), measured with the 28-8 pharmDx. Because the denominator is tumour cells only, CPS is not interchangeable with TPS or with the SP142 immune-cell score.

## Fields

- Kind: Biomarker
- Last checked: 2026-09-23
- Also known as: PD-L1 CPS; CPS; combined positive score; PD-L1 combined positive score; CPS >= 1; CPS >= 10; PD-L1 CPS 1; PD-L1 CPS 10; CPS≥1; CPS≥10
- Tags: biomarker; pd-l1

## Notes

- Triple-negative breast cancer: the pembrolizumab threshold is 22C3 CPS 10 or more, the KEYNOTE-355 subgroup whose overall survival was 23.0 versus 16.1 months (hazard ratio 0.73); CPS 1 or more did not reach significance (Cortes 2022). CPS 10 or more was 27.2% of 232 unselected early TNBCs and CPS 1 or more 53.9% (Sigurjonsdottir 2023); 80.9% of IMpassion130 samples were CPS 1 or more (Rugo 2021). The same threshold now gates sacituzumab govitecan plus pembrolizumab (ASCENT-04). CPS 10 and SP142 IC 1% agree weakly (kappa 0.48) and are not interchangeable.
- Gallbladder cancer: combined positive score was reported alongside TPS in 131 Western cases (Albrecht 2021); TOPAZ-1 and KEYNOTE-966 enrolled biliary patients regardless of PD-L1, so no CPS threshold applies to durvalumab or pembrolizumab in this cancer.

## Sources

- KEYTRUDA prescribing information (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287
- OPDIVO prescribing information (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394
- FDA: List of FDA-Authorized Companion Diagnostic Devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- biomarkers: [Claudin 18.2 expression (>= 75% of tumour cells, moderate to strong)](https://onco.cc/biomarkers/cldn18-2-expression/), [HLA-A*02:01 (HLA typing for TCR therapies)](https://onco.cc/biomarkers/hla-a-02-01/), [PD-L1 IC score (immune-cell score, SP142)](https://onco.cc/biomarkers/pd-l1-ic-score/), [PD-L1 TC score (tumour-cell score, SP263 and 28-8)](https://onco.cc/biomarkers/pd-l1-tc-score/), [PD-L1 TPS (tumour proportion score)](https://onco.cc/biomarkers/pd-l1-tps/), [Tissue factor expression](https://onco.cc/biomarkers/tissue-factor-expression/)
- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HER2-positive gastric cancer](https://onco.cc/cancers/gastric-her2-positive/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Oesophageal squamous cell carcinoma](https://onco.cc/cancers/oesophageal-squamous-cell-carcinoma/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [PD-L1-high gastric cancer](https://onco.cc/cancers/gastric-pdl1-high/), [Platinum-resistant ovarian cancer](https://onco.cc/cancers/platinum-resistant-ovarian-cancer/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [PD-L1 IHC 22C3 pharmDx](https://onco.cc/drugs/dako-pd-l1-22c3-pharmdx/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Sacituzumab govitecan](https://onco.cc/drugs/sacituzumab-govitecan/)
- terms: [Combined positive score (CPS)](https://onco.cc/terms/cps/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/), [PD-L1 expression testing (22C3, SP142, SP263)](https://onco.cc/terms/pd-l1-testing/)
- key papers: [Comparison of SP142 and 22C3 PD-L1 assays in a population-based cohort of triple-negative breast cancer patients in the context of their clinically established scoring algorithms](https://onco.cc/key-papers/paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023/), [KEYNOTE-355: pembrolizumab plus chemotherapy for PD-L1-positive advanced triple-negative breast cancer](https://onco.cc/key-papers/paper-keynote-355-nejm-2022/), [PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel-Treated Advanced Triple-Negative Breast Cancer](https://onco.cc/key-papers/paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021/), [Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial](https://onco.cc/key-papers/paper-keynote-355-lancet-2020/), [Programmed death ligand-1 (PD-L1) is an independent negative prognosticator in Western-world gallbladder cancer](https://onco.cc/key-papers/paper-albrecht-pdl1-western-gallbladder-cancers-2021/)
- targets: [PD-L1](https://onco.cc/targets/pdl1/)

---
JSON: https://onco.cc/api/v1/entities/pd-l1-cps.json