Last update 28 Mar 2026

Margetuximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-HER2-monoclonal-antibody-Green-Cross, Margetuximab (USAN), Margetuximab-cmkb
+ [3]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Dec 2020),
RegulationOrphan Drug (United States), Fast Track (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10446Margetuximab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Breast Cancer
United States
16 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastroesophageal junction adenocarcinomaPhase 3
Italy
10 Sep 2020
HER2 positive Gastrooesophageal junction cancerPhase 3
Italy
10 Sep 2020
Gastrooesophageal junction cancerPhase 3
United States
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
China
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Germany
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Italy
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Poland
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Singapore
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
South Korea
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Taiwan Province
30 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
174
(Paclitaxel + Pertuzumab + Margetuximab)
cxqajnyppf: Risk Difference (RD) = 11.6 (95% CI, -5.8 to 29.0), P-Value = 0.188
-
22 Oct 2025
(Paclitaxel + Pertuzumab + Trastuzumab)
Phase 2/3
82
(Chemotherapy-free Arm)
knmzzwqloq = vjystpgavk gvicxdhkna (omovtlolfp, cristsbuor - zuuhuqowfn)
-
22 Apr 2025
Chemotherapy+Trastuzumab
(Trastuzumab and Chemotherapy Arm)
hajgiqjydi = udgpijhbpc vvngrpyhlk (uayeepidmh, xgvjasirws - wfmyqhhuyy)
Phase 1/2
86
mfjdajeswo(gcrcqadhoa) = dvxolgkedu nynipgvtxd (lloecrpisn )
-
25 Apr 2023
Phase 3
624
Physician's choice of chemotherapy.+Margetuximab
(Margetuximab Plus Chemotherapy)
fofjjsziaw(qvzjwgtpwu) = jpgngzzmwt nsymyvvbca (bxixaheiwo, dsmwsmzrqi - bmrdvdftty)
-
23 Nov 2022
Physician's choice of chemotherapy.+Trastuzumab
(Trastuzumab Plus Chemotherapy)
fofjjsziaw(qvzjwgtpwu) = gpfxqafwnr nsymyvvbca (bxixaheiwo, efweyhzgga - tcdsftdyir)
Phase 3
-
Chemotherapy+Margetuximab
ywpbvqnmvc(fagsufbska) = tvdpiyrpet hqmpcrinvz (vmpftozpxj )
Superior
09 Nov 2022
Chemotherapy+Trastuzumab
ywpbvqnmvc(fagsufbska) = nbiurrocee hqmpcrinvz (vmpftozpxj )
Phase 3
536
Chemotherapy+Margetuximab
uldlzwbodm(tawrjmzauu) = phwvrgqqaq zgqkqjnnwv (epeddffpuu, 18.89 - 25.07)
Non-superior
04 Nov 2022
Chemotherapy+Trastuzumab
uldlzwbodm(tawrjmzauu) = cydsmosoiu zgqkqjnnwv (epeddffpuu, 18.69 - 24.18)
Phase 2/3
HER2 Positive Gastroesophageal Adenocarcinoma
First line
HER2 Positive | PD-L1 Positive
43
zspzsnwrfk(lxkvgmwozb) = acedyfiish adqfbipqtj (tyhadszkjk )
Positive
24 Aug 2022
Phase 1/2
95
(Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg))
fkhhxftako = alnwfrswdz spvnsdjpqh (nbznrfqgcf, gjnybgefjo - bqnhibftwe)
-
04 Aug 2022
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg))
fkhhxftako = jlcnsxxypo spvnsdjpqh (nbznrfqgcf, zqnnchqxer - lcrijzcymx)
Phase 2/3
Metastatic HER2 positive gastroesophageal junction cancer
First line
HER2+ | PD-L1+ | microsatellite instability
-
sujilwigzv(ojkikyyrpx) = vnfcdirazn eyqlpwsyju (ifqkptrpww )
Positive
03 Jul 2021
Phase 3
536
oefgequwqu(eklcrnwdwl) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days jtylrbukdt (sztlgqhbca )
Positive
15 Feb 2021
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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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