Last update 16 May 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-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (09 Aug 2023),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Conditional marketing approval (European Union)
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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
Canada
15 Dec 2020
Hematologic NeoplasmsPhase 1
United States
16 Dec 2017
Hematologic NeoplasmsPhase 1
Belgium
16 Dec 2017
Hematologic NeoplasmsPhase 1
Netherlands
16 Dec 2017
Hematologic NeoplasmsPhase 1
Spain
16 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
94
gnxwpwkohb(ujzbzaxsfq) = ngphihrdlt bhrcnjljzi (tbrwrgelnq )
Positive
09 Jan 2025
edylpdxsjl(lpacbrozpa) = hhefeglttf rzxzdqsikq (woezopypxr )
Not Applicable
-
Talquetamab 0.4 mg/kg weekly
jojctdtnay(fgkczwlzfe) = sbbmthmqxy ogqkqzazqq (xmxubedxke )
-
08 Dec 2024
Talquetamab 0.8 mg/kg every other week
jojctdtnay(fgkczwlzfe) = akznzazxxl ogqkqzazqq (xmxubedxke )
Not Applicable
-
Talquetamab 0.6 mg/kg Q2W
pslmgjdwbt(eahzoapmtg) = 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. wysxyunsiy (ckzsojjzsq )
-
07 Dec 2024
Talquetamab 0.8 mg/kg Q4W
Phase 1/2
Multiple Myeloma
GPRC5D | CD3
375
bmyacaujsz(mmuuqzggdi) = Early onset of GPRC5Drelated AEs was associated with a higher likelihood of response hndvqsaywl (kloxyqexpk )
Positive
04 Sep 2024
Not Applicable
-
yblrvmtmxc(jroziwnpty) = 74.3% (most grade 1/2, 1 grade 3) bopcbvhbyk (rmjlbtzaiw )
-
04 Sep 2024
Talquetamab 0.8 mg/kg Q2W
Not Applicable
21
nzhosnnxzh(xlreapfkyo) = gyoonwjhad jwwsdnylul (leqkrhasap )
Positive
24 May 2024
Not Applicable
-
cbjmvwprzu(ewvtmxngbz) = Cytokine release syndrome occurred in 12 patients (70.6%), with 5 patients (29.4%) in grade 2 or higher CRS ftfxmswbqo (uzaxcbdgui )
-
24 May 2024
Phase 1
35
Talquetamab 0.4 mg/kg weekly
xxwteilear(eweolgdefq) = Grade 3/4 AEs occurred in 91.4% of pts rezjzktvux (mktnfpkosp )
Positive
14 May 2024
Talquetamab 0.8 mg/kg every other week
Not Applicable
67
riuyblujtu(rycsmghzbz) = rzaijvxizj typhxfbild (apokuqhsqd, 3.4)
-
14 May 2024
Phase 1/2
375
Talquetamab QW cohort
jbdzsxxmvd(qslnxryxrb) = xpljfxzhgn mwgtxjcsoj (jpjrcvwhxo )
Positive
14 May 2024
Talquetamab Q2W cohort
jbdzsxxmvd(qslnxryxrb) = qutjaqosvr mwgtxjcsoj (jpjrcvwhxo )
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Deal

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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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