{"entity":{"id":"pd-l1-tc-score","kind":"biomarker","name":"PD-L1 TC score (tumour-cell score, SP263 and 28-8)","aka":["PD-L1 TC","TC score","tumor cell score","tumour cell score","TC >= 1%","TC >= 50%","PD-L1 >= 1% tumor cells","SP263 TC","28-8 TC","TC≥1%","TC≥50%"],"tldr":"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.","summary":"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.","asOf":"2026-09-23","links":[{"label":"TECENTRIQ prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6fa682c9-a312-4932-9831-f286908660ee"},{"label":"OPDIVO prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394"}],"tags":["biomarker","pd-l1"],"related":["pd-l1-cps","pd-l1-tps","pd-l1-ic-score"],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["atezolizumab","nivolumab","ipilimumab","ventana-pd-l1-sp263"],"companies":[],"institutions":[],"pathways":[],"terms":["pd-l1-testing","ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-herbst-impower110-atezolizumab-pd-l1-nejm-2020","paper-checkmate-026-first-line-nivolumab-nejm-2017","paper-blueprint-phase-2-pd-l1-assays-jto-2018"],"journals":[],"dependsOn":[],"notes":["Lung cancer: the tumour-cell score is what the 28-8 and SP263 assays report, and what SP142 reports alongside its immune-cell score. Thresholds in use are 1%, 5%, 10%, 25% and 50%, each belonging to the trial that drew it: CheckMate 026 randomised at 5% or more and failed (progression-free survival 4.2 against 5.9 months), while IMpower110 used the SP142 combination of tumour-cell 50% or more or immune-cell 10% or more and found overall survival of 20.2 against 13.1 months (Carbone 2017, Herbst 2020). Between-pathologist agreement on the tumour-cell read is excellent (intraclass correlation 0.86 to 0.93) (Tsao 2018)."],"target":"pdl1","measurement":"tumour-cell-score","scoringRule":{"text":"Percentage of tumour cells with membrane staining of any intensity on the SP263 or 28-8 assay; immune cells are not counted.","quote":"PD-L1 protein expression (PD-L1 stained ≥ 1% of tumor cells [TC ≥ 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":"PD-L1 on >= 1% of tumour cells (adjuvant)","drugId":"atezolizumab","cancerId":"nsclc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6fa682c9-a312-4932-9831-f286908660ee","quote":"as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test.","status":"current"},{"value":"TC >= 50% (or IC >= 10%)","drugId":"atezolizumab","cancerId":"nsclc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6fa682c9-a312-4932-9831-f286908660ee","quote":"whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%])","status":"current"},{"value":"PD-L1 >= 1% tumour cells (28-8 pharmDx)","drugId":"nivolumab","cancerId":"nsclc","regulator":"FDA","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","quote":"PD-L1 protein expression (tumor cell staining ≥1%)","status":"current","note":"FDA companion diagnostic row P150025/S013 (15 May 2020) for Opdivo in combination with Yervoy in NSCLC."}],"tests":[],"assays":["pdl1-sp263","pdl1-28-8"],"companionDiagnostics":[{"device":"Ventana PD-L1 (SP263) Assay","maker":"Ventana Medical Systems (Roche)","drugs":["atezolizumab"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P160046/S010 (10/15/2021)","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","ipilimumab"],"indication":"Non-small cell lung cancer (NSCLC) - Tissue","pma":"P150025/S013 (05/15/2020)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"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."},"route":"/biomarkers/pd-l1-tc-score/","neighbours":{"biomarker":[{"id":"pd-l1-cps","kind":"biomarker","name":"PD-L1 CPS (combined positive score)","route":"/biomarkers/pd-l1-cps/"},{"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-tps","kind":"biomarker","name":"PD-L1 TPS (tumour proportion score)","route":"/biomarkers/pd-l1-tps/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"ventana-pd-l1-sp263","kind":"drug","name":"VENTANA PD-L1 (SP263) Assay","route":"/drugs/ventana-pd-l1-sp263/"}],"term":[{"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-rimm-pd-l1-assay-comparison-jama-oncol-2017","kind":"paper","name":"A prospective, multi-institutional, pathologist-based assessment of 4 immunohistochemistry assays for PD-L1 expression in non-small cell lung cancer","route":"/key-papers/paper-rimm-pd-l1-assay-comparison-jama-oncol-2017/"},{"id":"paper-herbst-impower110-atezolizumab-pd-l1-nejm-2020","kind":"paper","name":"Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC","route":"/key-papers/paper-herbst-impower110-atezolizumab-pd-l1-nejm-2020/"},{"id":"paper-checkmate-026-first-line-nivolumab-nejm-2017","kind":"paper","name":"CheckMate 026: first-line nivolumab in stage IV or recurrent non-small-cell lung cancer","route":"/key-papers/paper-checkmate-026-first-line-nivolumab-nejm-2017/"},{"id":"paper-checkmate-227-n-engl-j-med-2018","kind":"paper","name":"Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden","route":"/key-papers/paper-checkmate-227-n-engl-j-med-2018/"},{"id":"paper-hirsch-j-thorac-oncol","kind":"paper","name":"PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project","route":"/key-papers/paper-hirsch-j-thorac-oncol/"},{"id":"paper-blueprint-phase-2-pd-l1-assays-jto-2018","kind":"paper","name":"PD-L1 immunohistochemistry comparability study in real-life clinical samples: results of Blueprint phase 2 project","route":"/key-papers/paper-blueprint-phase-2-pd-l1-assays-jto-2018/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}]}}