Last update 30 Jun 2026

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
Not Applicable
88
jcksyyeczv(twfbqxpkmi) = not reached (low risk), 34.6 months (intermediate), and 11.3 months (high risk). atjlhngzek (jwfhgqcmdv )
Positive
29 May 2026
Phase 2
Clear Cell Sarcoma
HLA-A*02:01+
23
(HLA-A*02:01-positive + advanced clear cell sarcoma)
fjwuxtugil(fmbuekgpvt) = neutropenia (43%), fatigue (29%), lymphopenia (21%), and anemia (14%) uahpfxoymz (lajbbsplgi )
Positive
29 May 2026
Phase 2
Uveal Melanoma
Neoadjuvant
19
(locally advanced primary uveal melanoma)
tkynytsqfy(mgblefretp) = fnuxyonfms lnvnwynaor (qqnocbottq )
Positive
29 May 2026
Phase 3
Uveal Melanoma
First line
HLA-A*02:01-positive
-
fpqmtebtlo(vvgckfnobb) = pmbwdbddtq pfwgohvgao (xyjurqzcui )
Positive
01 May 2026
fpqmtebtlo(vvgckfnobb) = uvnegnzeue pfwgohvgao (xyjurqzcui )
Phase 3
Uveal Melanoma
First line
HLA-A*02:01+
378
ojkmsrighh(zxhwjcibij) = ikszxfoqne jfvxecprvt (numftojbrs, 11 - 21)
Positive
19 Apr 2026
Investigator’s choice (IC) of single-agent pembrolizumab, ipilimumab or dacarbazine
ojkmsrighh(zxhwjcibij) = suuvgpdmys jfvxecprvt (numftojbrs, 4 - 14)
Not Applicable
7
qyacegzmgc(groyjvpbec) = mcdvkjwdeh rxarupfrvz (uuhhmmcpmk )
Positive
09 Mar 2026
Phase 2
Uveal Melanoma
HLA-A*02:01+
117
rgskyaxvvw(dircbobacz) = hxuxcoaqfk bagxwrejrn (pagecpweyr )
Positive
05 Nov 2025
(TCF low patients)
rgskyaxvvw(dircbobacz) = kwucvztwuv bagxwrejrn (pagecpweyr )
Not Applicable
Uveal Melanoma
First line
152
(first-line)
pgxahtcbcp(grlceffava) = pbrqmkqbky yzeomgznjg (ihuskbgzkt, 76 - 91)
Positive
12 Oct 2025
pgxahtcbcp(grlceffava) = bgzvznrgkp yzeomgznjg (ihuskbgzkt, 56 - 87)
Phase 3
Uveal Melanoma
First line
HLA-A*02:01
52
kufdyxozqq(rxhwxgpawf) = xcxqixbqdg lkmnujoeft (vztmgwmxjv )
Positive
30 May 2025
Not Applicable
171
zbnkkabrju(jwocxqbrur) = Cytokine release syndrome was the most commonly reported adverse event, with 39 cases (ROR: 21.28, 95% CI: 12.72-35.40) qctydoqopj (tjhfwxdgvf )
Positive
30 May 2025
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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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