{"entity":{"id":"pd-l1-cps","kind":"biomarker","name":"PD-L1 CPS (combined positive score)","aka":["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"],"tldr":"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.","asOf":"2026-09-23","links":[{"label":"KEYTRUDA prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287"},{"label":"OPDIVO prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394"},{"label":"FDA: List of FDA-Authorized Companion Diagnostic Devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["biomarker","pd-l1"],"related":["pd-l1-tps","pd-l1-ic-score","pd-l1-tc-score"],"cancers":["head-and-neck","gastric","gastric-her2-positive","gastric-pdl1-high","esophageal","oesophageal-squamous-cell-carcinoma","cervical","tnbc","tnbc-metastatic","ovarian","platinum-resistant-ovarian-cancer","gallbladder"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","nivolumab","sacituzumab-govitecan","dako-pd-l1-22c3-pharmdx"],"companies":[],"institutions":[],"pathways":[],"terms":["cps","pd-l1-testing","ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-keynote-355-nejm-2022","paper-keynote-355-lancet-2020","paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023","paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021","paper-albrecht-pdl1-western-gallbladder-cancers-2021"],"journals":[],"dependsOn":[],"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."],"target":"pdl1","measurement":"combined-positive-score","scoringRule":{"text":"Count PD-L1-positive tumour cells, lymphocytes and macrophages; divide by the number of viable tumour cells; multiply by 100. A specimen must hold at least 100 viable tumour cells to be scored.","quote":"PD-L1 protein expression [Combined Positive Score (CPS) ≥ 1]","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","sourceLabel":"FDA: List of FDA-Authorized Companion Diagnostic Devices"},"thresholds":[{"value":"CPS >= 1","drugId":"pembrolizumab","cancerId":"head-and-neck","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test.","status":"current"},{"value":"CPS >= 1","drugId":"pembrolizumab","cancerId":"gastric","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.","status":"current"},{"value":"CPS >= 1","drugId":"pembrolizumab","cancerId":"gastric-her2-positive","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1)","status":"current"},{"value":"CPS >= 1 (with chemotherapy); CPS >= 10 (single agent, squamous, after prior therapy)","drugId":"pembrolizumab","cancerId":"esophageal","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10)","status":"current"},{"value":"CPS >= 1","drugId":"pembrolizumab","cancerId":"cervical","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.","status":"current"},{"value":"CPS >= 10","drugId":"pembrolizumab","cancerId":"tnbc-metastatic","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test","status":"current"},{"value":"CPS >= 10","drugId":"sacituzumab-govitecan","cancerId":"tnbc-metastatic","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.","status":"current"},{"value":"CPS >= 1","drugId":"pembrolizumab","cancerId":"platinum-resistant-ovarian-cancer","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test","status":"current"},{"value":"PD-L1 >= 1 (28-8 pharmDx)","drugId":"nivolumab","cancerId":"gastric","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394","quote":"OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1)","status":"current"},{"value":"PD-L1 >= 1 (28-8 pharmDx)","drugId":"nivolumab","cancerId":"oesophageal-squamous-cell-carcinoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394","quote":"OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1)","status":"current"}],"tests":["omniseq-insight","caris-mi-profile"],"assays":["pdl1-22c3","pdl1-28-8"],"companionDiagnostics":[{"device":"PD-L1 IHC 22C3 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["pembrolizumab"],"indication":"Head and Neck Squamous Cell Carcinoma (HNSCC) - Tissue","pma":"P150013/S014 (06/10/2019)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"PD-L1 IHC 22C3 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["pembrolizumab"],"indication":"Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma - Tissue","pma":"P150013/S027 (11/07/2023)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"PD-L1 IHC 22C3 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["pembrolizumab"],"indication":"Esophageal or Gastroesophageal Junction (GEJ) Carcinoma - Tissue","pma":"P150013/S032 (02/11/2026)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"PD-L1 IHC 22C3 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["pembrolizumab"],"indication":"Cervical Cancer - Tissue","pma":"P150013/S009 (06/12/2018)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"PD-L1 IHC 22C3 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["pembrolizumab"],"indication":"Triple-Negative Breast Cancer (TNBC) - Tissue","pma":"P150013/S020 (11/13/2020)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"PD-L1 IHC 22C3 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["pembrolizumab"],"indication":"Epithelial Ovarian, Fallopian Tube Cancer, or Primary Peritoneal Carcinoma (EOC) - Tissue","pma":"P150013/S033 (02/10/2026)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"PD-L1 IHC 28-8 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["nivolumab"],"indication":"Esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma - Tissue","pma":"P150025/S018 (07/01/2026)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"Your report gives a CPS number. Whether it counts as positive depends on the cancer: the pembrolizumab label asks for 1 or more in head and neck, stomach, oesophageal, cervical and platinum-resistant ovarian cancer, and 10 or more in triple-negative breast cancer. The same number can open a treatment in one cancer and not in another, and a score below the cut-off does not mean immunotherapy can never be used, only that this particular indication does not apply."},"route":"/biomarkers/pd-l1-cps/","neighbours":{"biomarker":[{"id":"cldn18-2-expression","kind":"biomarker","name":"Claudin 18.2 expression (>= 75% of tumour cells, moderate to strong)","route":"/biomarkers/cldn18-2-expression/"},{"id":"hla-a-02-01","kind":"biomarker","name":"HLA-A*02:01 (HLA typing for TCR therapies)","route":"/biomarkers/hla-a-02-01/"},{"id":"pd-l1-ic-score","kind":"biomarker","name":"PD-L1 IC score (immune-cell score, SP142)","route":"/biomarkers/pd-l1-ic-score/"},{"id":"pd-l1-tc-score","kind":"biomarker","name":"PD-L1 TC score (tumour-cell score, SP263 and 28-8)","route":"/biomarkers/pd-l1-tc-score/"},{"id":"pd-l1-tps","kind":"biomarker","name":"PD-L1 TPS (tumour proportion score)","route":"/biomarkers/pd-l1-tps/"},{"id":"tissue-factor-expression","kind":"biomarker","name":"Tissue factor expression","route":"/biomarkers/tissue-factor-expression/"}],"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"gastric-her2-positive","kind":"cancer","name":"HER2-positive gastric cancer","route":"/cancers/gastric-her2-positive/"},{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"oesophageal-squamous-cell-carcinoma","kind":"cancer","name":"Oesophageal squamous cell carcinoma","route":"/cancers/oesophageal-squamous-cell-carcinoma/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"gastric-pdl1-high","kind":"cancer","name":"PD-L1-high gastric cancer","route":"/cancers/gastric-pdl1-high/"},{"id":"platinum-resistant-ovarian-cancer","kind":"cancer","name":"Platinum-resistant ovarian cancer","route":"/cancers/platinum-resistant-ovarian-cancer/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"dako-pd-l1-22c3-pharmdx","kind":"drug","name":"PD-L1 IHC 22C3 pharmDx","route":"/drugs/dako-pd-l1-22c3-pharmdx/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"term":[{"id":"cps","kind":"term","name":"Combined positive score (CPS)","route":"/terms/cps/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"},{"id":"pd-l1-testing","kind":"term","name":"PD-L1 expression testing (22C3, SP142, SP263)","route":"/terms/pd-l1-testing/"}],"paper":[{"id":"paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023","kind":"paper","name":"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","route":"/key-papers/paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023/"},{"id":"paper-keynote-355-nejm-2022","kind":"paper","name":"KEYNOTE-355: pembrolizumab plus chemotherapy for PD-L1-positive advanced triple-negative breast cancer","route":"/key-papers/paper-keynote-355-nejm-2022/"},{"id":"paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021","kind":"paper","name":"PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel-Treated Advanced Triple-Negative Breast Cancer","route":"/key-papers/paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021/"},{"id":"paper-keynote-355-lancet-2020","kind":"paper","name":"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","route":"/key-papers/paper-keynote-355-lancet-2020/"},{"id":"paper-albrecht-pdl1-western-gallbladder-cancers-2021","kind":"paper","name":"Programmed death ligand-1 (PD-L1) is an independent negative prognosticator in Western-world gallbladder cancer","route":"/key-papers/paper-albrecht-pdl1-western-gallbladder-cancers-2021/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}]}}