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

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.

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.

Part ofHLA-A· HLA-A All readouts

HLA-A: what it is and how drugs act on it · animated schematic, not to scale

Target · the protein and the cell it sits on
Drug · antibody, small molecule, cell or radioligand
Effect · signal, damage or kill

In plain words · HLA-A is the molecule that holds up short pieces of a cell's proteins for T cells to inspect. Engineered T-cell receptor therapies such as tebentafusp and afami-cel only work in people with the HLA-A*02 variant, because the receptor recognises the tumour peptide sitting in that particular groove.

HLA typing 2 approval thresholds

What it means for a patient

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.

Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.

Scoring rule

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.

“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.”
FDA: List of FDA-Authorized Companion Diagnostic Devices

Thresholds used in approvals

Threshold	Drug	Cancer	Regulator	Source
HLA-A*02:01-positive	Tebentafusp	Uveal melanoma	FDA	label
HLA-A02:01P, -A02:02P, -A02:03P or -A02:06P positive and MAGE-A4-expressing	Afamitresgene autoleucel	Synovial sarcoma	FDA	label

Drugs whose label names it

Tebentafusp Afamitresgene autoleucel

Companion diagnostics (FDA list)

Device	Maker	Indication and sample	Drug	PMA / 510(k)
SeCore CDx HLA Sequencing System	One Lambda (Thermo Fisher Scientific)	Uveal Melanoma - Whole Blood	Tebentafusp	BR220737 (11/28/2022)
SeCore CDx HLA Sequencing System	One Lambda (Thermo Fisher Scientific)	Synovial sarcoma - Whole blood	Afamitresgene autoleucel	BK241074 (08/01/2024)
MAGE-A4 IHC 1F9 pharmDx	Agilent Technologies	Synovial sarcoma - Tissue	Afamitresgene autoleucel	P230016 (08/01/2024)

Trials that name this readout

Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.