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Drug

Tebentafusp

Approved medicine

Primarily used for Melanoma.

ClassMelanocyte protein PMEL binding agentResearchOngoing clinical research

Also known as Kimmtrak.

RxNorm2590743ChEMBLCHEMBL4297990ATCL01XX75UNIIN658GY6L3E
2
Research papers
9
Active clinical trials
Melanocyte protein PMEL
Primary target
1
Regulatory events
Latest activity
beta

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

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

Clinical trial2026-10-02Results expected Q4 2030 · ClinicalTrials.gov

Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma

Clinical trial2026-09-15Results 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 trial2026-09-09Results expected Q3 2028 · ClinicalTrials.gov

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

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 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

Marketing authorisation: 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
1
emaEuropean Medicines Agency· 1 event
2022-04-01Original application approval
Marketing authorisation: 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
10
registered trials across all phases
9
Active studies
8
Recruiting
2
Late-stage (III+)
1
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 11Phase 1 / 21Phase 26Phase 32

Research activity

2 papers

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

Publications over time
2021–2023
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
Recent papers

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

The New England journal of medicine · 2023 · 190 cites

Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma.

The New England journal of medicine · 2021 · 685 cites
Major research themes4
Antineoplastic Combined Chemotherapy Protocols1Melanoma1Recombinant Fusion Proteins1Uveal Neoplasms1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
Leading researchers
  • Baurain JF2
  • Butler MO2
  • Carvajal RD2
  • Curti B2
  • Demidov L2
  • Dummer R2
  • Gastaud L2
  • Hamid O2
Leading institutions
free-text, unnormalised
  • From Mount Vernon Cancer Centre1
  • From the University Hospital Heidelberg1

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

3 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
Ipilimumab

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.