KIMMTRAK (tebentafusp-tebn)
KIMMTRAK is indicated for the treatment of Uveal Melanoma.
How KIMMTRAK Works
Tebentafusp-tebn works by bridging T cells and tumor cells to facilitate an immune response. The molecule's T cell receptor arm binds to a gp100 peptide presented by HLA-A*02:01 on the surface of uveal melanoma cells. This interaction activates polyclonal T cells to release inflammatory cytokines and cytolytic proteins, resulting in the direct lysis of the tumor cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-01-25
- Patent Cliff
- 2029
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KIMMTRAK Approval History
What KIMMTRAK Treats
1 indicationsKIMMTRAK is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Uveal Melanoma
KIMMTRAK Boxed Warning
CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours fol...
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated ( 2.2 , 5.1 ).
KIMMTRAK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in KIMMTRAK's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KIMMTRAK treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06414590 | iRISID-2023-2369 JT 33504 | Ph 2 | recruiting | Neoadjuvant Tebentafusp for Uveal Melanoma |
| NCT07276386 | MCC-23724 | Ph 2 | recruiting | Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma |
| NCT07057596 NEO-TB | GEM 2302 2023-509076-42-00 | Ph 2 | recruiting | Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma |
| NCT06246149 ATOM | EORTC-2022-MG EU trial number | Ph 3 | recruiting | Adjuvant Tebentafusp in High Risk Ocular Melanoma |
| NCT06070012 | HCC 22-165 | Ph 2 | recruiting | Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma |
| NCT05549297 | IMCgp100-203 | Ph 3 | recruiting | Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) |
| NCT06627244 | 20231324 | Ph 2 | recruiting | Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma |
| NCT06942442 | SARC045 | Ph 2 | recruiting | A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma |
| NCT06626516 | 2024-3117 JT 31444 | Ph 1, Ph 2 | recruiting | Tebentafusp-tebn With LDT in Metastatic UM |
| NCT05315258 TebeMRD | OCTO_101 2019-003946-34 | Ph 2 | active not recruiting | Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma |
| NCT05785754 | DCSZ11-101 | Ph 1 | recruiting | DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KIMMTRAK FDA Label Details
Indications & Usage
FDA Label (PDF)KIMMTRAK is indicated for the treatment of Uveal Melanoma.
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment