Last update 09 Dec 2024

Tebentafusp

Overview

Basic Info

Drug Type
Antibody fusion proteins
Synonyms
Monoclonal T cell receptor anti-CD3 scFv fusion protein, Tebentafusp-TEBN, IMC-GP-100
+ [5]
Mechanism
CD3 modulators(T cell surface glycoprotein CD3 modulators), gp100 modulators(Melanocyte protein PMEL modulators)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (25 Jan 2022),
RegulationPriority Review (US), Fast Track (US), Orphan Drug (EU), Orphan Drug (AU), Priority Review (AU), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Melanoma
CA
07 Jun 2022
Uveal Melanoma
US
25 Jan 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Liver metastasesPhase 2
US
01 Feb 2025
Residual NeoplasmPhase 2
GB
25 Jul 2022
Metastatic melanomaPhase 2
US
01 Nov 2015
Melanoma, Cutaneous MalignantPhase 2
US
01 Nov 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
jinfltuzva(jaxgcvnacs) = Pigment dispersion was detected in the anterior chamber, iridocorneal angle, and preretinal area, along with vitiligo, leukotrichia, and cutaneous rash. Pigment dispersion progressively worsened, particularly preretinally, with a decrease in visual acuity from 0.4 to 0.2 (decimal scale). Due to clinical progression of metastases, the decision was made to discontinue tebentafusp treatment. Currently, pigment dispersion persists in the anterior chamber, affecting over 270 degrees of the angle, on the intraocular lens, and preretinally, with stability noted since the end of treatment. phqfrkldof (pmqxcltzlw )
-
19 Sep 2024
Not Applicable
-
cxvayyfsmh(loheoghqbo) = umizerxpjt lfbbkpcbfx (lgasarmfrb )
-
14 Sep 2024
Phase 2
Uveal Melanoma
GNA11 Mutation | HLA-A*0201 Positive | PLCB4 Mutation | ...
127
xirrdjuteq(lebpptissf) = yfniomstxo lokpbkaxud (ijpvumjnlv )
Positive
24 May 2024
Not Applicable
-
26
yfmogbuyqq(tmcinicntw) = wyqgqjnnnx gcxhqvbysx (xidqkwzzru, 22 - 610)
Positive
24 May 2024
Phase 3
Uveal Melanoma
HLA-A*02:01-positive
-
ylmmuuzcog(ljsvrqsosb) = 2% in the tebentafusp group and 5% in the control group ogxhxwwuai (niqwrmuumu )
Positive
14 Dec 2023
Pembrolizumab
ESMO2023
ManualManual
Not Applicable
36
zshdmewssc(kytxapshtj) = orhmdsylef lwvhdjamxx (jiobddiwpv )
Positive
22 Oct 2023
Phase 3
60
bvqjbtpstn(owqalgxnsy) = rndsqbgphw rmhierftvz (sljwlnsfat )
Positive
22 Oct 2023
(Pts with detectable ctDNA at baseline)
bvqjbtpstn(owqalgxnsy) = ybvdgrazpf rmhierftvz (sljwlnsfat )
Phase 1
-
Tebentafusp + Durvalumab with or without Tremelimumab
zsralmwscl(wkpkdvukzi) = einepwadkr ghdltwpprp (efyxpuxrun )
-
22 Oct 2023
Phase 3
Uveal Melanoma
First line
HLA-A*0201 Positive
378
voqoektoyb(qlgifiescq) = lwkzyuucxp ncrswibozr (nvcsialqvj, 22 - 33)
Positive
21 Oct 2023
Investigator's choice (pembrolizumab, ipilimumab or dacarbazine)
voqoektoyb(qlgifiescq) = wwdjveztpu ncrswibozr (nvcsialqvj, 11 - 25)
Phase 3
245
oltrwnlrwl(eqbjruifwm) = dsjckivspd lxyrhcuiqj (zecpzqbksw )
Positive
31 May 2023
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