{"entity":{"id":"pd-l1-tps","kind":"biomarker","name":"PD-L1 TPS (tumour proportion score)","aka":["PD-L1 TPS","TPS","tumor proportion score","tumour proportion score","TPS >= 1%","TPS >= 50%","PD-L1 TPS 50","PD-L1 high","PD-L1 ≥50%","TPS≥50%","TPS≥1%"],"tldr":"TPS is the share of tumour cells whose membrane stains for PD-L1, ignoring immune cells. In lung cancer it decides whether pembrolizumab or cemiplimab can be given alone: 1 percent opens the door, 50 percent is where single-agent treatment is strongest.","summary":"The tumour proportion score is the percentage of viable tumour cells showing partial or complete membrane staining at any intensity, read on the 22C3 pharmDx (and, for cemiplimab, also the SP263 assay). Pembrolizumab's US label uses TPS >= 1 percent for first-line single-agent treatment of stage III or metastatic NSCLC without EGFR or ALK alterations and for second-line treatment after platinum chemotherapy; cemiplimab's single-agent first-line indication requires TPS >= 50 percent. The KEYNOTE-024 trial that set the 50 percent bar and KEYNOTE-042 that lowered the gate to 1 percent are the sources of the two numbers. TPS is a lung-specific read; the same slide scored as CPS would include immune cells and give a different number.","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":"LIBTAYO prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4347ae1f-d397-4f18-8b70-03897e1c054a"}],"tags":["biomarker","pd-l1"],"related":["pd-l1-cps","pd-l1-ic-score","pd-l1-tc-score"],"cancers":["nsclc","lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","cemiplimab","dako-pd-l1-22c3-pharmdx","ventana-pd-l1-sp263"],"companies":[],"institutions":[],"pathways":[],"terms":["tps","pd-l1-testing","ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"target":"pdl1","measurement":"tumour-proportion-score","scoringRule":{"text":"Percentage of viable tumour cells with partial or complete membrane staining of any intensity; at least 100 viable tumour cells must be present.","quote":"PD-L1 protein expression [Tumor Proportion Score (TPS) ≥ 50%]","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":"TPS >= 1%","drugId":"pembrolizumab","cancerId":"nsclc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.","status":"current"},{"value":"TPS >= 1% (after platinum chemotherapy)","drugId":"pembrolizumab","cancerId":"nsclc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","quote":"KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy.","status":"current"},{"value":"TPS >= 50%","drugId":"cemiplimab","cancerId":"nsclc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4347ae1f-d397-4f18-8b70-03897e1c054a","quote":"LIBTAYO as a single agent is indicated for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations","status":"current"}],"tests":["omniseq-insight"],"assays":["pdl1-22c3","pdl1-sp263"],"companionDiagnostics":[{"device":"PD-L1 IHC 22C3 pharmDx","maker":"Agilent Technologies (Dako)","companyId":"agilent","drugs":["pembrolizumab"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P150013 (10/02/2015); updated P150013/S012 (04/16/2019)","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":["cemiplimab"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P150013/S021 (02/22/2021)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"Ventana PD-L1 (SP263) Assay","maker":"Ventana Medical Systems (Roche)","drugs":["cemiplimab"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P160046/S013 (03/01/2023)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"In lung cancer the report gives a percentage of tumour cells. At 50 percent or more the labels allow pembrolizumab or cemiplimab on their own as first treatment; between 1 and 49 percent pembrolizumab alone is still on label but chemotherapy combinations are usually chosen; below 1 percent immunotherapy is given with chemotherapy rather than alone. The score does not apply if the tumour has an EGFR or ALK alteration, which take priority."},"route":"/biomarkers/pd-l1-tps/","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-tc-score","kind":"biomarker","name":"PD-L1 TC score (tumour-cell score, SP263 and 28-8)","route":"/biomarkers/pd-l1-tc-score/"}],"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"cemiplimab","kind":"drug","name":"Cemiplimab","route":"/drugs/cemiplimab/"},{"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":"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/"},{"id":"tps","kind":"term","name":"Tumour proportion score (TPS)","route":"/terms/tps/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}]}}