{"entity":{"id":"hla-a-02-01","kind":"biomarker","name":"HLA-A*02:01 (HLA typing for TCR therapies)","aka":["HLA-A*02:01","HLA-A2","HLA-A*02:01-positive","HLA-A0201","HLA typing","HLA-A*02"],"tldr":"HLA-A*02:01 is the commonest tissue-type molecule in people of European descent and the one the first T-cell receptor therapies were built for. Tebentafusp and afamitresgene autoleucel work only in patients who carry it, so a blood HLA test comes before the tumour test.","summary":"HLA typing by sequencing (the SeCore CDx HLA Sequencing System is the FDA-listed companion diagnostic for both drugs) reports the patient's HLA-A alleles. Tebentafusp (Kimmtrak) is labelled for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma; afamitresgene autoleucel (Tecelra) for synovial sarcoma in patients who are HLA-A*02:01P, -A*02:02P, -A*02:03P or -A*02:06P positive and whose tumour expresses MAGE-A4 by the MAGE-A4 IHC 1F9 pharmDx, with HLA-A*02:05P as an exclusion allele. About 45 percent of Europeans and fewer people of African or East Asian ancestry carry A*02:01, which limits access and drives development of TCR therapies for other alleles.","asOf":"2026-09-23","links":[{"label":"KIMMTRAK prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067"},{"label":"TECELRA prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab24631f-3364-46e1-8074-7244863bcbab"}],"tags":["biomarker","hla"],"related":["pd-l1-cps"],"cancers":["uveal-melanoma","synovial-sarcoma","melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tebentafusp","afamitresgene-autoleucel"],"companies":[],"institutions":[],"pathways":[],"terms":["hla-a02-restriction","uveal-melanoma-prognostic-markers"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"target":"hla-a","measurement":"hla-typing","scoringRule":{"text":"Presence of the HLA-A*02:01 allele (for tebentafusp) or of HLA-A*02:01P, A*02:02P, A*02:03P or A*02:06P without A*02:05P (for afamitresgene autoleucel) by HLA sequencing of blood.","quote":"Eligible alleles: HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 and their P-group alleles. Exclusion alleles: HLA-A*02:05 and its P-group alleles.","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":"HLA-A*02:01-positive","drugId":"tebentafusp","cancerId":"uveal-melanoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067","quote":"KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.","status":"current"},{"value":"HLA-A*02:01P, -A*02:02P, -A*02:03P or -A*02:06P positive and MAGE-A4-expressing","drugId":"afamitresgene-autoleucel","cancerId":"synovial-sarcoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab24631f-3364-46e1-8074-7244863bcbab","quote":"TECELRA is indicated for the treatment of adults and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.","status":"current"}],"tests":[],"assays":[],"companionDiagnostics":[{"device":"SeCore CDx HLA Sequencing System","maker":"One Lambda (Thermo Fisher Scientific)","companyId":"thermo-fisher","drugs":["tebentafusp"],"indication":"Uveal Melanoma - Whole Blood","pma":"BR220737 (11/28/2022)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"SeCore CDx HLA Sequencing System","maker":"One Lambda (Thermo Fisher Scientific)","companyId":"thermo-fisher","drugs":["afamitresgene-autoleucel"],"indication":"Synovial sarcoma - Whole blood","pma":"BK241074 (08/01/2024)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"MAGE-A4 IHC 1F9 pharmDx","maker":"Agilent Technologies","companyId":"agilent","drugs":["afamitresgene-autoleucel"],"indication":"Synovial sarcoma - Tissue","pma":"P230016 (08/01/2024)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"Your HLA type is inherited and tested from a blood sample. If you carry HLA-A*02:01, tebentafusp is on label for advanced uveal melanoma, the only drug shown to extend survival in that disease, and afamitresgene autoleucel is an option for synovial sarcoma if the tumour also expresses MAGE-A4. If you do not carry the allele these particular treatments cannot work, and trials for other HLA types are the route to ask about."},"route":"/biomarkers/hla-a-02-01/","neighbours":{"biomarker":[{"id":"pd-l1-cps","kind":"biomarker","name":"PD-L1 CPS (combined positive score)","route":"/biomarkers/pd-l1-cps/"}],"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"synovial-sarcoma","kind":"cancer","name":"Synovial sarcoma","route":"/cancers/synovial-sarcoma/"},{"id":"uveal-melanoma","kind":"cancer","name":"Uveal melanoma","route":"/cancers/uveal-melanoma/"}],"drug":[{"id":"afamitresgene-autoleucel","kind":"drug","name":"Afamitresgene autoleucel","route":"/drugs/afamitresgene-autoleucel/"},{"id":"tebentafusp","kind":"drug","name":"Tebentafusp","route":"/drugs/tebentafusp/"}],"term":[{"id":"hla-a02-restriction","kind":"term","name":"HLA-A*02:01 restriction","route":"/terms/hla-a02-restriction/"},{"id":"uveal-melanoma-prognostic-markers","kind":"term","name":"Uveal melanoma prognostic markers (GNAQ/GNA11, monosomy 3, gene-expression class)","route":"/terms/uveal-melanoma-prognostic-markers/"}],"target":[{"id":"hla-a","kind":"target","name":"HLA-A","route":"/targets/hla-a/"}]}}