Drug

Tebentafusp

Approved · EMA

ClassMelanocyte protein PMEL binding agentEmerging researchLate-stage development

Also known as Kimmtrak.

RxNorm2590743 ChEMBLCHEMBL4297990 ATCL01XX75UNIIN658GY6L3E

Research papers

Active clinical trials

Melanocyte protein PMEL

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*02:01 Positive Patients Following Definitive Treatment of High-risk Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)

Clinical trial2026-06-30Results expected Q4 2032 · ClinicalTrials.gov

Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma

Clinical trial2026-03-31Results expected Q4 2030 · ClinicalTrials.gov

Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma

Clinical trial2026-03-06Results expected Q4 2027 · ClinicalTrials.gov

Phase II Open-label, Multi-center Study of Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (mUM) With Integrated Circulating Tumor DNA (ctDNA) Biomarker (TARGET-tebe)

Clinical trial2026-02-27Results expected Q3 2028 · ClinicalTrials.gov

Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)

Clinical trial2026-02-25Results expected Q1 2028 · ClinicalTrials.gov

Phase 2, Single Arm Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma

Clinical trial2026-02-23Results expected Q1 2028 · ClinicalTrials.gov

A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma

Clinical trial2025-12-26Results expected Q4 2030 · ClinicalTrials.gov

A Phase II Non-Randomized, Open-label, Multi-centre Study of the Safety and Efficacy of Tebentafusp in Melanoma With Molecular Relapsed Disease

Clinical trial2025-07-17Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors

Clinical trial2025-06-26Results expected Q4 2026 · ClinicalTrials.gov

Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma.

Research2023-10-21The New England journal of medicine

Approval: Kimmtrak (EMA)

Regulatory2022-04-01EMA

Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma.

Research2021-09-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Tebentafusp

Aliases & brands

Kimmtrak

RxNorm CUI

2590743

ChEMBL ID

CHEMBL4297990

ATC codes

L01XX75

UNII

N658GY6L3E

Primary mechanism

Melanocyte protein PMEL binding agent

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Melanocyte protein PMEL

PMEL · P40967

BINDING AGENTMelanocyte protein PMEL binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2022-04-01

Latest approval

2022-04-01

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2022-04-01Approval

Approval: Kimmtrak (EMA)

Indication: Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

Active studies

Recruiting

Late-stage (III+)

Discontinued

PHASE DISTRIBUTIONn = 10

Phase 11Phase 1 / 21Phase 26Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*02:01 Positive Patients Following Definitive Treatment of High-risk Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)

RecruitingPH IIIEuropean Organisation for Research and Treatment of Cancer - EORTCn=2902032

RecruitingPH IIIImmunocore Ltdn=5402028

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20212023

Most influential

Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma.

The New England journal of medicine · 2021 · 685 cites

Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma.

The New England journal of medicine · 2023 · 190 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Melanoma2

Active research areas

Uveal Neoplasms2

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Dacarbazine

Studied across 4 of the same disease areas as Tebentafusp in the shared literature.

4 shared diseases1 shared paper

Pembrolizumab

Studied across 4 of the same disease areas as Tebentafusp in the shared literature.

4 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.