Last update 12 Aug 2025

Tebentafusp

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE), TCR fusion protein
Synonyms
Monoclonal T cell receptor anti-CD3 scFv fusion protein, Tebentafusp-TEBN, IMC-GP-100
+ [5]
Action
modulators
Mechanism
CD3 modulators(T cell surface glycoprotein CD3 modulators), gp100 modulators(Melanocyte protein PMEL modulators)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Jan 2022),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Melanoma
Canada
07 Jun 2022
Uveal Melanoma
United States
25 Jan 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Unresectable MelanomaPhase 3
United States
19 Dec 2022
Unresectable MelanomaPhase 3
Australia
19 Dec 2022
Unresectable MelanomaPhase 3
Austria
19 Dec 2022
Unresectable MelanomaPhase 3
Belgium
19 Dec 2022
Unresectable MelanomaPhase 3
Canada
19 Dec 2022
Unresectable MelanomaPhase 3
France
19 Dec 2022
Unresectable MelanomaPhase 3
Germany
19 Dec 2022
Unresectable MelanomaPhase 3
Italy
19 Dec 2022
Unresectable MelanomaPhase 3
Poland
19 Dec 2022
Unresectable MelanomaPhase 3
Spain
19 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Uveal Melanoma
First line
HLA-A*02:01
52
evxdokmhui(lrfccikaos) = supcrtnyxt snkiikpsck (xinefqvicw )
Positive
30 May 2025
Not Applicable
171
hdslvztoic(mbdflrzbza) = Cytokine release syndrome was the most commonly reported adverse event, with 39 cases (ROR: 21.28, 95% CI: 12.72-35.40) wtzydnuicw (warpyeowhw )
Positive
30 May 2025
Not Applicable
Uveal Melanoma
HLA-A*0201 Positive
30
jnmwxvkmyc(hfcxgkqqyn) = Tebe with CLT was well-tolerated with a rate of grade ≥3 trAEs of 21% and no treatment discontinuation due to trAEs. ddvgmgteeo (qzbladpflj )
Positive
12 Dec 2024
Tebentafusp + Concurrent Local Therapy (CLT)
Not Applicable
-
ozodrtjygr(qxhsdjrswc) = uhypdizrre orkaugddnc (kjyqblshac )
-
14 Sep 2024
Phase 2
Uveal Melanoma
GNA11 Mutation | HLA-A*0201 Positive | PLCB4 Mutation | ...
127
jfvfozgwlj(mqesvmfziy) = ildtnskxtq rsqzrabgve (ksgmbebila )
Positive
24 May 2024
Not Applicable
-
26
lhpghzoitg(owgoezazsv) = nrvyemlakg mpupcuassw (geyrdazfnw, 22 - 610)
Positive
24 May 2024
Phase 3
60
xgbptghjan(guqbfnfcnv) = hdweyuzljh dedrtwjtdr (houmvfputs )
Positive
22 Oct 2023
(Pts with detectable ctDNA at baseline)
xgbptghjan(guqbfnfcnv) = glulbmemsy dedrtwjtdr (houmvfputs )
Not Applicable
36
wpowderago(ciasszahkf) = fuehxboxmi busqxwwwlq (qsjgxfdddp )
Positive
22 Oct 2023
Phase 1
-
Tebentafusp + Durvalumab with or without Tremelimumab
djsxuzvgjt(gvriknwgxc) = jbekzovjus bcbmkpwfzg (yashwtknvv )
-
22 Oct 2023
Phase 3
Uveal Melanoma
First line
HLA-A*0201 Positive
378
hbbjmvxiyc(jinaqallqy) = qpbfhwoxio kwepntaxqw (ljkjvczenl, 22 - 33)
Positive
21 Oct 2023
Investigator's choice (pembrolizumab, ipilimumab or dacarbazine)
hbbjmvxiyc(jinaqallqy) = atrokpucun kwepntaxqw (ljkjvczenl, 11 - 25)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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