PGx tebentafusp

Synonyms: HLA-A*02:01

Material:

EDTA blood
(1 ml)

TAT:

1 week

Method:

NGS, SSO

Overview

Tebentafusp (KIMMTRAK®) is a novel immunotherapy approved for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, a rare and aggressive cancer arising from melanocytes within the eye. Tebentafusp was the first therapy to demonstrate a significant overall survival benefit in metastatic uveal melanoma and represents an important advance in precision oncology.

Unlike many cancer therapies that are selected based on tumor mutations, tebentafusp requires the presence of a specific HLA type. Only patients who carry HLA-A*02:01 are eligible for treatment because the drug’s mechanism of action depends on this HLA molecule.

As a result, HLA-A02:01 testing is mandatory before treatment initiation. Patients who do not carry HLA-A02:01 are not expected to benefit from tebentafusp.

PGx tebentafusp

1 Gene(s)*

HLA-A

Pharmacological background

What is HLA-A*02:01?

HLA-A*02:01 is a specific variant of the HLA-A gene, which belongs to the human leukocyte antigen (HLA) system. HLA molecules are responsible for presenting peptide antigens to T cells and play a central role in immune recognition.

The HLA type of an individual is inherited and remains unchanged throughout life. HLA types vary between individuals and populations. Approximately 40–50% of people of European ancestry carry HLA-A*02:01, although frequencies differ across ethnic groups.

For most people, HLA-A*02:01 has no direct clinical significance. However, it becomes critically important when considering treatment with tebentafusp.

What is tebentafusp?

Tebentafusp is a first-in-class bispecific T-cell receptor (TCR) therapy designed to redirect the immune system against melanoma cells.

The drug consists of two functional components:

A high-affinity T-cell receptor that recognizes the melanoma-associated antigen gp100 when presented by HLA-A*02:01
An anti-CD3 domain that recruits and activates T cells

By linking tumor cells to cytotoxic T cells, tebentafusp enables the immune system to recognize and attack malignant cells that would otherwise evade immune detection.

This mechanism explains why treatment is restricted to patients who express HLA-A*02:01: without the appropriate HLA molecule, the drug cannot effectively bind and initiate its anti-tumor activity.

Uveal melanoma

Uveal melanoma is the most common primary cancer of the eye in adults, but it remains a rare disease overall. Despite successful treatment of the primary tumor, approximately 30–50% of patients eventually develop metastatic disease, most frequently involving the liver.

Historically, treatment options for metastatic uveal melanoma have been limited, and outcomes have been poor. Conventional immunotherapies used successfully in cutaneous melanoma generally demonstrate lower efficacy in uveal melanoma.

Tebentafusp has become the first therapy to significantly improve overall survival in this patient population.

Tested variants

Result interpretation

Test limitations

Clinical relevance

Indication	ICD-10	Gene
Uveal melanoma	C69.4	HLA-A

References

Created by

Our editorial team consists of medical specialists and scientists in the field of human genetics. All content is created and reviewed in accordance with current scientific standards.

Last content review: August 4, 2026. As pharmacogenomic evidence and recommendations continue to evolve, the information presented on this page may not always reflect the latest updates. For current guidance and annotations, please refer to .

Last Update : 24.09.2026

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