Last update 27 Feb 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),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States), Breakthrough Therapy (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
Malignant melanoma, metastaticPhase 3
United States
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Australia
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Austria
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Belgium
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Canada
01 Sep 2023
Malignant melanoma, metastaticPhase 3
France
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Germany
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Italy
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Poland
01 Sep 2023
Malignant melanoma, metastaticPhase 3
Spain
01 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Uveal Melanoma
HLA-A*02:01+
117
rixxubluqe(pevrrunvxv) = woodouqiwm rnrgifyulw (eudhzmkbzi )
Positive
05 Nov 2025
(TCF low patients)
rixxubluqe(pevrrunvxv) = xryzrotglm rnrgifyulw (eudhzmkbzi )
Not Applicable
Uveal Melanoma
First line
152
(first-line)
zpuraopaim(jfyjqclxov) = edaavrtqgh qqjzsvdhhm (lfnykeonab, 76 - 91)
Positive
12 Oct 2025
zpuraopaim(jfyjqclxov) = uxpgezgzhp qqjzsvdhhm (lfnykeonab, 56 - 87)
Phase 3
Uveal Melanoma
First line
HLA-A*02:01
52
fyaptqrxaa(jjxzswuvyw) = rcjxafbjco ntjahkxiil (kyomtjtcsr )
Positive
30 May 2025
Not Applicable
171
bhpuflviwt(hflvmbyazo) = Cytokine release syndrome was the most commonly reported adverse event, with 39 cases (ROR: 21.28, 95% CI: 12.72-35.40) gtwcekaakc (wslgixaqbb )
Positive
30 May 2025
Not Applicable
40
xtmljntlcd(xejzfyexeo) = fpxbsydzeq xyuhswgoip (yhzarvrdfp )
Positive
07 Mar 2025
Not Applicable
Uveal Melanoma
HLA-A*0201 Positive
30
wtwdaiehff(xglpesvimh) = Tebe with CLT was well-tolerated with a rate of grade ≥3 trAEs of 21% and no treatment discontinuation due to trAEs. ewzvbwuxqh (comuewdiqf )
Positive
12 Dec 2024
Tebentafusp + Concurrent Local Therapy (CLT)
Not Applicable
-
gwyymrsskk(gtdyqimaqz) = tvufrqxbns aqebvhscjm (ddhkmwlnnl )
-
14 Sep 2024
Phase 2
Uveal Melanoma
GNA11 Mutation | HLA-A*0201 Positive | GNAQ Mutation | ...
127
gqwcotgenm(pqdechufac) = nqtzjhwqcb scstbmdgto (dnwcnjqxbh )
Positive
24 May 2024
Not Applicable
-
26
yqklxpllhe(wolhjtusdo) = zhsnbgtjhz azfmoodiyj (xatzngdktd, 22 - 610)
Positive
24 May 2024
Phase 3
Uveal Melanoma
HLA-A*02:01+
378
(prior tebe patients)
syfmpkgkks(lrgpttfcjp) = In an analysis of survival from the start of any first subsequent therapy, prior tebe patients tended to have longer OS compared to prior IC patients, HR (95% CI) 0.75 (0.55, 1.04). This difference was also seen when restricting to patients who received subsequent CPI therapy, HR (95% CI) 0.72 (0.48, 1.09). hwbfcqgvcx (jyvvubvfzs )
Positive
22 Oct 2023
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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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