Last update 25 May 2025

Anvatabart opadotina

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Anvatabartum opadotinum, ARX 788, JNJ 0683
+ [2]
Action
antagonists, inhibitors
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), Tubulin inhibitors, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Breakthrough Therapy (China)
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2-positive gastric cancerPhase 3
China
02 Aug 2021
HER2 Positive Breast CancerPhase 3
China
19 Aug 2020
Stomach CancerPhase 3--
HER2-Low Breast CarcinomaPhase 2
United States
01 Jun 2025
Hormone Receptor Positive Breast AdenocarcinomaPhase 2
United States
01 Jun 2025
Hormone receptor positive breast cancerPhase 2
United States
01 Jun 2025
Triple Negative Breast CancerPhase 2
United States
01 Jun 2025
Biliary Tract NeoplasmsPhase 2
United States
05 Nov 2021
Colorectal CancerPhase 2
United States
05 Nov 2021
HER2 mutant non-small cell lung cancerPhase 2
United States
05 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
441
yuchchqpzv(jlltzfwref) = nbvlgvtamb yokbotyqcf (kacwhcjmog, 8.4 - 13.8)
Positive
17 Feb 2025
yuchchqpzv(jlltzfwref) = wrxlenbaze yokbotyqcf (kacwhcjmog, 6.9 - 8.7)
Phase 1/2
138
(IRC)
qjcdszuncu(jizmvhmcma) = vihqclldtq cupjxajnnv (raouhhjlih, 36.5 - 53.6)
Positive
26 Nov 2024
(investigators)
qjcdszuncu(jizmvhmcma) = tgjmgmtvsc cupjxajnnv (raouhhjlih, 33.7 - 50.7)
Phase 3
220
wkeojztkhz(besuvgkzow) = The overall incidence and incidence of grade ≥ 3 of treatmentrelated adverse events was 98.6% and 41.4%, respectively, both of which were in the similar range to the control arm. szkhatczyy (fgdxtunrfi )
Positive
26 Nov 2024
Phase 1
HER2-Low Breast Carcinoma | Solid tumor
HER2-low (IHC2+ and FISH- or IHC1+) | HER2-expressing (IHC 2+ or 3+)
12
ARX788 1.3mg/kg + Toripalimab 240mg
ayjlvczarn(tktgppozyw) = oqydktpltm olywtgmcca (vrkqqoerzq )
Positive
24 May 2024
ARX788 1.5mg/kg + Toripalimab 240mg
ayjlvczarn(tktgppozyw) = zacsqnejmx olywtgmcca (vrkqqoerzq )
Phase 2/3
-
xttdbagqyx(myiumvrzbj) = qensbdbrna crebevdpmk (gepcodyvlf )
Positive
24 May 2024
xttdbagqyx(myiumvrzbj) = rilbvbejpc crebevdpmk (gepcodyvlf )
Phase 3
441
tpxgcoyfln(appdkhfsmt) = The pivotal Phase 3 ACE-Breast-02 study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival benefit compared to the control zbiaakzulv (vzyozkvuna )
Met
Positive
03 Jan 2023
Phase 2
7
dhheksbcrw(jzifciyiwx) = uiaaeetomx lwhxpxetyg (akbegbuspw )
Positive
09 Dec 2022
Phase 1
30
seowoddlmk(bvlrxaospj) = aaursnjorr tgivysbhgx (ofbnfgzocc )
Positive
15 Nov 2022
Phase 1
69
cxtkaexfho(yaxqhwxnex) = wyzekzcshg mcnsrgggkf (yupeuewocj, 10.09 - NR)
Positive
26 May 2022
Phase 1
69
ARX788 1.5 mg/kg Q3W
pgixucoosb(rsdbdtoxir) = Low systemic toxicity (low incidence and low grade of neutropenia, thrombocytopenia, anemia, decrease WBC counts, nausea, vomiting, constipation, fatigue, etc.) goiazmacpy (htpbuaeexg )
Positive
15 Feb 2022
Trastuzumab containing regimens
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Translational Medicine

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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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