Kimmtrak (tebentafusp-tebn)
Antineoplastic - Immunotherapy, T-cell Engager Intravenous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Tebentafusp-tebn, a bispecific gp100 peptide-HLA-directed CD3 T cell engager, is an antineoplastic agent.
Tebentafusp-tebn, a first-in-class bispecific glycoprotein 100 (gp100) peptide-human leukocyte antigen (HLA)-directed CD3 T cell engager, is an antineoplastic agent. Tebentafusp-tebn is a recombinant fusion protein composed of a T-cell receptor (TCR) arm and an anti-CD3 single chain variable fragment. The TCR arm targets the melanoma-associated antigen, gp100 presented by HLA-A*02:01, and the anti-CD3 T-cell engaging domain enables polyclonal activation of native T cells, which release cytokines and cytolytic proteins that target and kill gp100-expressing tumor cells.
Lymphocyte counts decline the day following the first 3 doses of tebentafusp-tebn and return to baseline prior to subsequent doses. Serum levels of cytokines (IFN-gamma, TNFalpha, IL-2, IL-6, IL-10 and IL-1RA) and chemokines (CXCL9, CXCL10, CXCL11, hepatocyte growth factor, and monocyte chemoattractant protein-1) increase during treatment. Peak levels occur 8 to 24 hours after tebentafusp infusion and return to baseline prior to subsequent doses.
Cytokine elevation occurs in fewer patients with lesser intensity after the first 3 doses. Tebentafusp-tebn plasma concentrations increase in a dose proportional manner. The drug is expected to be catabolized into small peptides and amino acids and has a medial terminal half-life of 7.5 hours.
Treatment emergent anti-drug antibodies (ADA) were detected in 29% of patients in the principle efficacy study. The median ADA titer in the ADA-positive subgroup of patients was 8192 across 67 treatment cycles. Systemic exposure of tebentafusp-tebn decreased by 97% and the terminal half-life decreased to 10-14 minutes in patients with ADA titers greater than 8192.
Limited data suggest ADAs have no clinically important effect on frequency or severity of hypersensitivity reactions or overall survival. Age (23 to 91 years), weight (43 to 163 kg), and sex (48% female) do not have a clinically important effect on the pharmacokinetics of tebentafusp-tebn.
USES: This medication is used to treat a certain type of cancer (uveal melanoma). Tebentafusp belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.
Generic name: tebentafusp-tebn
Pronunciation: (te-BEN-ta-fusp)
Drug class: Antineoplastic - Immunotherapy, T-cell Engager
Therapeutic class: Antineoplastics
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Kimmtrak
Indications
The following indications are listed for Kimmtrak:
- Uveal Melanoma In Hla-A *02:01 Positive Patient
Also known as: Melanoma Of Uvea In Hla-A *02:01 Positive Patient.
Dosing
No dosage reductions are recommended for tebentafusp-tebn. Interruption of therapy and/or discontinuation of tebentafusp may be necessary based on the severity of the adverse effect.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Kimmtrak 100 Mcg/0.5 Ml Vial | Maintenance | Infuse 68 mcg over 15-20 minute(s) by intravenous route once weekly. |
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been performed to date with tebentafusp-tebn.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
- Lactation
- Pregnancy
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions (occurring in >=30%) are CRS, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting. The most common laboratory abnormalities (occurring in >=50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
More Frequent
- Cytokine release syndrome
- Hypotension
Less Frequent
- Anemia
- Elevated serum lipase
- Hypertension
- Hypoalbuminemia
- Hypocalcemia
- Hypomagnesemia
- Hypophosphatemia
- Increased alanine transaminase
- Increased aspartate transaminase
- Lymphopenia
- Neutropenic disorder
- Thrombocytopenic disorder
More Frequent
- Acute abdominal pain
- Chills
- Dry skin
- Edema
- Fatigue
- Fever
- Headache disorder
- Nausea
- Pruritus of skin
- Skin rash
- Vomiting
Less Frequent
- Alopecia
- Anorexia
- Arthralgia
- Back pain
- Constipation
- Diarrhea
- Dizziness
- Dyschromia
- Dyspnea
- Flu-like symptoms
- Flushing
- Hair discoloration
- Hyperglycemia
- Muscle spasm
- Myalgia
- Night sweats
- Pain in extremities
- Pain in oropharynx
- Paresthesia
- Skin hypopigmentation
- Tachycardia
Precautions
No enhanced messaging available.
Safety and efficacy of tebentafusp-tebn have not been established in pediatric patients.
Tebentafusp-tebn may cause fetal harm based on its mechanism of action. There are no tebentafusp data in pregnant women and no animal reproductive and developmental toxicity studies have been conducted to date. Molecules of similar weight can cross the placenta, exposing the fetus. Advise women of the potential risk to the fetus.
It is not known whether tebentafusp-tebn distributes into milk in humans or animals or whether the drug has any effects on breastfed infants or on milk production. Because of the potential for serious adverse reactions to tebentafusp in breastfed infants, women should be advised to discontinue breastfeeding during tebentafusp therapy and for 1 week after the last dose.
No dosage adjustment is necessary.
No overall differences in safety or efficacy were observed between patients >=65 years of age compared with younger adults. In the principle efficacy study, nearly half of the patients treated with tebentafusp-tebn were >=65 years of age and 9% were >=75 years of age.
ICD codes
| Code | Type | Description |
|---|---|---|
| Uveal melanoma in HLa-A *02:01 positive patient | ||
| C69.3 | ICD10CM | Malignant neoplasm of choroid |
| C69.30 | ICD10CM | Malignant neoplasm of unspecified choroid |
| C69.31 | ICD10CM | Malignant neoplasm of right choroid |
| C69.32 | ICD10CM | Malignant neoplasm of left choroid |
| C69.4 | ICD10CM | Malignant neoplasm of ciliary body |
| C69.40 | ICD10CM | Malignant neoplasm of unspecified ciliary body |
| C69.41 | ICD10CM | Malignant neoplasm of right ciliary body |
| C69.42 | ICD10CM | Malignant neoplasm of left ciliary body |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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