Last update 24 Jun 2025

Talquetamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
DuoBody, TALQUETAMAB-TGVS, JNJ 64407564
+ [6]
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), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), Priority Review (China)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Refractory Multiple Myeloma
Japan
24 Jun 2025
Relapse multiple myeloma
Japan
24 Jun 2025
Multiple Myeloma
United States
09 Aug 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Peripheral Stem Cell TransplantationPhase 2
United States
01 Nov 2025
Residual NeoplasmPhase 2
United States
01 Jun 2025
Smoldering Multiple MyelomaPhase 2
United States
04 Dec 2023
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 2
90
Talquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kg
nnhtdccwfz(avrgcgzcry) = kmdksvesaz wknbxcpqdo (rxlosotqzr )
Positive
03 Jun 2025
Phase 1/2
-
gkplbuzhiy(jrfzdwrcdj) = most common adverse events (AE) sqgpzijsyy (iftynwzujh )
Positive
30 May 2025
Not Applicable
Cytokine Release Syndrome
CD3 | BCMA | GPRC5D
17
pdummwkywe(unkprqofpu) = developed in 72.1% of patients in MajesTEC-1 and 76% of patients in MonumenTAL-1 pzlbhcjavo (kaqcstezjw )
Positive
30 May 2025
Phase 1/2
363
quqozgdboi(itjehuoxoq) = ggldrubsyq aqxhhvzznr (xcegdshzux )
Positive
22 May 2025
quqozgdboi(itjehuoxoq) = hkeiowkoug aqxhhvzznr (xcegdshzux )
Phase 1
44
Talquetamab 0.4 mg/kg + Cetrelimab 80 mg
wdfocwtuct(atofnxrdga) = fcybunzwro myxlaltxdi (dyqxcbrgvi )
Positive
14 May 2025
Talquetamab 0.8 mg/kg + Cetrelimab 160 mg
wdfocwtuct(atofnxrdga) = hfiwyjkwav myxlaltxdi (dyqxcbrgvi )
Not Applicable
53
gcljbvnzsd(ybojjstpow) = jsarpxvxsv yneotbqgae (njfbjnesqr, 44% - 93%)
-
14 May 2025
Not Applicable
75
Talquetamab 0.4 mg/kg weekly
oztlxhadom(cttcjacggv) = eqmpfhzqgt zxphpbdazi (xzlvkcrgll )
Positive
14 May 2025
(Real-World Physician's Choice)
oztlxhadom(cttcjacggv) = yaakilnxtz zxphpbdazi (xzlvkcrgll )
Not Applicable
-
28
Talquetamab SUD in outpatient setting
padyvoxxxo(rprixelhjf) = Supportive care treatment for CRS included tocilizumab (38.5%), dexamethasone (57.7%), and acetaminophen (57.7%) rkqyeumpho (clqywwqjqj )
-
14 May 2025
Not Applicable
175
Talquetamab 0.4 mg/kg weekly
ktpodknaxx(hslhvmhlhc) = pkekhrtgym yhhjfrbmfb (emfgwejwbv )
Positive
14 May 2025
Talquetamab 0.8 mg/kg every other week
ktpodknaxx(hslhvmhlhc) = uzznovwrxy yhhjfrbmfb (emfgwejwbv )
Not Applicable
125
mensoxrzzp(iwldqszziw) = 71 pts (57%) vvjlqdrwyo (ikovhhvoms )
Positive
14 May 2025
B-cell maturation antigen (BCMA)-targeted therapies
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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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