Tebentafusp

Tebentafusp-tebn is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumor cells.

• KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).ICD-10: C43.9

• None. None ( 4 ).contraindicated

Recommended dosage: 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week thereafter ( 2.2 ). Dilute and administer by intravenous infusion over 15-20 minutes ( 2.2 , 2.4 ). See Full Prescribing Information for instructions on preparation and administration of the diluted solution for intravenous infusion ( 2.2 , 2.4 ). Dosage interruption or permanent discontinuation may be required based on individual safety and tolerability ( 2.3 ). 2.1 Patient Selection Select patients for treatment of unresectable or metastatic uveal melanoma with KIMMTRAK based on a positive HLA-A*02:01 genotyping test of a whole blood sample [see Clinical Studies (14) ] . Information on FDA-approved tests is available at http://www.fda.gov/companiondiagnostics . 2.2 Recommended Dosage The recommended dosage of KIMMTRAK administered intravenously is: 20 mcg on Day 1 30 mcg on Day 8 68 mcg on Day 15 68 mcg once every week thereafter Treat patients until unacceptable toxicity or disease progression occur. Administer the first three infusions of KIMMTRAK in an appropriate healthcare setting by intravenous infusion over 15-20 minutes. Monitor patients during the infusion and for at least 16 hours after the infusion is complete.

Skin reactions : Rash, pruritus, and cutaneous edema occurred in patients treated with KIMMTRAK. If skin reactions occur, treat based on persistence and severity of symptoms ( 2.3 , 5.2 ). Elevated liver enzymes : Elevations in liver enzymes occurred in patients treated with KIMMTRAK. Monitor ALT, AST, and total bilirubin ( 2.3 , 5.3 ). Embryo-Fetal toxicity : May cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception ( 5.4 , 8.1 , 8.3 ). 5.1 Cytokine Release Syndrome Cytokine release syndrome (CRS), which may be life threatening, occurred in patients receiving KIMMTRAK. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS (≥ Grade 2) occurred in 77% of patients in Study IMCgp100-202 who received KIMMTRAK [see Adverse Reactions (6.1) ] . Among patients who received KIMMTRAK, 23% received systemic corticosteroids for at least 1 infusion, 8% received supplemental oxygen during at least 1 infusion, and 0.8% received a vasopressor for at least 1 infusion. CRS led to permanent discontinuation in 1.2% of patients. In Study IMCgp100-202, 60% of patients experienced ≥ Grade 2 CRS with more than 1 infusion, with the median number of events being 2 (range 1 - 12). The majority (84%) of episodes of CRS started the day of infusion. Among cases that resolved, the median time to resolution of CRS was 2 days.

The following serious adverse reactions are discussed in greater detail in other sections of the label: Cytokine Release Syndrome [ see Boxed Warning , Warnings and Precautions (5.1) ] Skin Reactions [ see Warnings and Precautions (5.2) ] Elevated Liver Enzymes [ see Warnings and Precautions (5.3) ] The most common adverse reactions (occurring in ≥ 30%) are cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting ( 6.1 ). The most common laboratory abnormalities (occurring in ≥50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased aspartate aminotransferase, increased alanine aminotransferase, decreased hemoglobin, and decreased phosphate ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Immunocore at 1-844-IMMUNO1 (1-844-466-8661) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. First line metastatic uveal melanoma The safety of KIMMTRAK was evaluated in study IMCgp100-202, a randomized (2:1), open-label, active-controlled trial in patients who had not received prior systemic therapy for metastatic or advanced uveal melanoma [see Clinical Studies (14) ] .

8.1 Pregnancy Risk Summary Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with KIMMTRAK in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK. Molecules of similar molecular weight can cross the placenta resulting in fetal exposure. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of tebentafusp-tebn in human milk, the effect on the breastfed child, or the effects on milk production. Because tebentafusp-tebn may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with KIMMTRAK and for at least 1 week after the last dose. 8.3 Females and Males of Reproductive Potential KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating KIMMTRAK treatment.

Metabolism

After a single dose administration, tebentafusp-tebn C max and AUC 0-7d increased in an approximately dose proportional manner from 20 to 68 mcg (0.3 to 1 times the approved recommended dose). Following administration of the approved recommended dosage in patients with metastatic uveal melanoma, the steady-state geometric mean (% CV) C max of tebentafusp-tebn is 13 ng/mL (34.6%) and AUC 0-7d is 4.6 ng.day/mL (23%) with no accumulation.

• Jan 25, 2022BLABLA761228Immunocore Ltd

1. 1Cytokine Release Syndrome10619%
2. 2Pyrexia9818%
3. 3Disease Progression7113%
4. 4Rash6512%
5. 5Hypotension6211%
6. 6Chills5510%
7. 7Malignant Neoplasm Progression5510%
8. 8Product Dose Omission Issue519.3%
9. 9Pruritus407.3%
10. 10Nausea366.6%
11. 11Vomiting325.8%
12. 12Death315.7%
13. 13Fatigue224.0%
14. 14Asthenia173.1%
15. 15Tachycardia173.1%

The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Tebentafusp as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Neoadjuvant Tebentafusp for Uveal Melanoma
  Recruiting · Phase 2 · Interventional · 19 enrolled · Thomas Jefferson University
  NCT06414590updated 2026-06-12
• Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
  Recruiting · Phase 1 · Interventional · 8 enrolled · St Vincent's Hospital, Sydney
  NCT07203391updated 2026-04-23
• Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
  Recruiting · Interventional · 2,050 enrolled · Institut Curie
  NCT05088395updated 2026-04-14
• Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
  Recruiting · Phase 2 · Interventional · 18 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT07276386updated 2026-03-31
• Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
  Completed · Phase 2 · Interventional · 378 enrolled · Immunocore Ltd
  NCT03070392updated 2026-03-17
• Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 410 enrolled · Immunocore Ltd
  NCT04262466updated 2026-03-06
• Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
  Recruiting · Phase 2 · Interventional · 19 enrolled · Grupo Español Multidisciplinar de Melanoma
  NCT07057596updated 2026-03-06
• Adjuvant Tebentafusp in High Risk Ocular Melanoma
  Recruiting · Phase 3 · Interventional · 290 enrolled · European Organisation for Research and Treatment of Cancer - EORTC
  NCT06246149updated 2026-03-04
• Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
  Recruiting · Phase 2 · Interventional · 44 enrolled · Diwakar Davar
  NCT06070012updated 2026-02-27
• Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
  Recruiting · Phase 3 · Interventional · 540 enrolled · Immunocore Ltd
  NCT05549297updated 2026-02-25

Frequently asked questions

How does Tebentafusp work?

Tebentafusp-tebn is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumor cells.

What is Tebentafusp used for?

According to FDA labeling, Tebentafusp carries indications including: KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tebentafusp?

Tebentafusp is classified as Other antineoplastic agents, Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager, Antibody-Surface Glycolipid Interactions, CD3-directed Antibody Interactions, CD3 Receptor Agonists, G-Protein-linked Receptor Interactions, Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions, Increased Cytokine Activity.

What are the brand names for Tebentafusp?

Tebentafusp is marketed under brand names including Kimmtrak.

What are the contraindications for Tebentafusp?

Tebentafusp labeling lists contraindications including: None. None ( 4 ).. Always consult the full prescribing information and a clinician.