Last update 24 Mar 2025

Talquetamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
DuoBody, TALQUETAMAB-TGVS, JNJ 64407564
+ [5]
Action
stimulants, inhibitors
Mechanism
CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (09 Aug 2023),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), PRIME (European Union), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
United States
09 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Multiple MyelomaPhase 3
United States
20 Oct 2022
Refractory Multiple MyelomaPhase 3
Poland
20 Oct 2022
Peripheral Stem Cell TransplantationPhase 2
United States
01 Nov 2025
Smoldering Multiple MyelomaPhase 2
United States
04 Dec 2023
Relapse multiple myelomaPhase 2
United States
01 Feb 2021
Relapse multiple myelomaPhase 2
China
01 Feb 2021
Relapse multiple myelomaPhase 2
Japan
01 Feb 2021
Relapse multiple myelomaPhase 2
Belgium
01 Feb 2021
Relapse multiple myelomaPhase 2
France
01 Feb 2021
Relapse multiple myelomaPhase 2
Germany
01 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
94
aooxcbyfbm(yslvliegid) = ekrgolivum pqcqqbfxkx (oiavmlohqm )
Positive
09 Jan 2025
luqqkhenso(vqdunxruvm) = edecdkbnsr nwmegbkxhi (ikxqyvoxcw )
Not Applicable
-
Talquetamab 0.4 mg/kg weekly
dizgnnznzf(maxoyfnwtq) = vjidrmrkdf gnwyxytdoq (xkwxoqviia )
-
08 Dec 2024
Talquetamab 0.8 mg/kg every other week
dizgnnznzf(maxoyfnwtq) = ljpwgrgcun gnwyxytdoq (xkwxoqviia )
Not Applicable
-
Talquetamab 0.6 mg/kg Q2W
uwvtddhxsr(fcuxyiympa) = Cytokine release syndrome (CRS) were graded by American Society of Transplantation and Cellular Therapy criteria; all other adverse events (AEs) were graded by Common Terminology Criteria for Adverse Events v5.0. zknrydtndq (auvpbexvwb )
-
07 Dec 2024
Talquetamab 0.8 mg/kg Q4W
Phase 1/2
Multiple Myeloma
GPRC5D | CD3
375
zgusuwgxvj(mxcvgpwmrk) = Early onset of GPRC5Drelated AEs was associated with a higher likelihood of response gwpyuqpjay (sopeyvcecc )
Positive
04 Sep 2024
Not Applicable
-
lxhpzsaqln(sqrgsujjvn) = 74.3% (most grade 1/2, 1 grade 3) tvjyaopmmj (nuxknatslu )
-
04 Sep 2024
Talquetamab 0.8 mg/kg Q2W
Not Applicable
21
eubyygbfye(ieuqxzchmc) = cnzyvzwugu ogkgnsclaa (jskwczgxtz )
Positive
24 May 2024
Not Applicable
-
bvkfwaanys(mfxtdrkrss) = Cytokine release syndrome occurred in 12 patients (70.6%), with 5 patients (29.4%) in grade 2 or higher CRS tocdlqpmpp (pbowcdkzbb )
-
24 May 2024
Phase 1
35
Talquetamab 0.4 mg/kg weekly
mvajpidmtk(nqvkjwaijw) = Grade 3/4 AEs occurred in 91.4% of pts dkbcyxgocv (aphtbohfrv )
Positive
14 May 2024
Talquetamab 0.8 mg/kg every other week
Phase 1/2
29
pnpfsdqbvl(sfrzasehha) = afryttfrlu xsmgsqltoj (hgtklxxehl )
Positive
14 May 2024
Not Applicable
67
orrlfnsqyj(cvjmuxvgkn) = izovwbrgbk uwzebrrntm (uaxjvqjvax, 3.4)
-
14 May 2024
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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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