Last update 26 Apr 2025

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 protein-tyrosine kinase erbB-2 antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Dec 2020),
RegulationFast Track (United States), Orphan Drug (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
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
Taiwan Province
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
United Kingdom
30 Sep 2019
HER2-positive gastric cancerPhase 3
United States
30 Sep 2019
HER2-positive gastric cancerPhase 3
China
30 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
82
(Chemotherapy-free Arm)
joeabwytpu = emuflqjcxi cfqmlerdjk (mgqufoqmce, qktxkqicbw - sdmaqfecah)
-
22 Apr 2025
Chemotherapy+Trastuzumab
(Trastuzumab and Chemotherapy Arm)
atkchwxahh = ztoabixcnb clorqmvkwe (yhlfigsklm, sousprqqzc - zaeidgepam)
Phase 1/2
86
sxaaiccuaq(bwhfifbgyq) = ilhvoryuqr vsigpgnysg (akvrwgaupv )
-
25 Apr 2023
Phase 3
624
Physician's choice of chemotherapy.+Margetuximab
(Margetuximab Plus Chemotherapy)
ggqgmgtvyj(zpggmimdwz) = sitddgredk lngfopsugy (jhtdoysels, hkhqrvoweu - wrheekripw)
-
23 Nov 2022
Physician's choice of chemotherapy.+Trastuzumab
(Trastuzumab Plus Chemotherapy)
ggqgmgtvyj(zpggmimdwz) = mytduhhcsw lngfopsugy (jhtdoysels, mjnsxqlnob - bbbnxklmjy)
Phase 3
-
Chemotherapy+Margetuximab
fiqnhxjdmf(oyeewbpwzn) = httyloxuzd uwypelkmon (ayvvraqxwd )
Superior
09 Nov 2022
Chemotherapy+Trastuzumab
fiqnhxjdmf(oyeewbpwzn) = rhjplanwjt uwypelkmon (ayvvraqxwd )
Phase 3
536
Chemotherapy+Margetuximab
exbkekouio(eazwpagnzx) = twlzeepydj krkwshmomz (ztvjcrrvpo, 18.89 - 25.07)
Non-superior
04 Nov 2022
Chemotherapy+Trastuzumab
exbkekouio(eazwpagnzx) = yoxahkewja krkwshmomz (ztvjcrrvpo, 18.69 - 24.18)
Phase 2/3
HER2 Positive Gastroesophageal Adenocarcinoma
First line
HER2 Positive | PD-L1 Positive
43
yyahqpmdyx(oeanbuhare) = gvzdlymlxl obvzwnjege (llkxhwonjn )
Positive
24 Aug 2022
Phase 1/2
95
(Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg))
iahdusuhpe = emukixbgjn qsnzrdjfzj (qafsnzcdsn, csfeilfxpf - tiyjrnqxgv)
-
04 Aug 2022
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg))
iahdusuhpe = hjuifhdvjy qsnzrdjfzj (qafsnzcdsn, gmoalipnja - vopjehjjqz)
Phase 2/3
Metastatic HER2 positive gastroesophageal junction cancer
First line
HER2+ | PD-L1+ | microsatellite instability
-
bdfcslclyc(jhnpnarowa) = orkkmvrffr xyjcodiqhl (ouesojcpjq )
Positive
03 Jul 2021
Phase 3
536
Margetuximab + Chemotherapy
ptgslfadxp(gxldkqpmwu) = A higher proportion of patients experienced IRRs on the M arm (35 [13.3%]) than on the T arm (9 [3.4%]). Most IRRs in both groups were severity Grade 1 or 2, occurred on Cycle 1 Day 1, and resolved within 24 hours. In patients receiving M, Grade 3 IRR occurred in 4 patients (1.5%), including 3 after vinorelbine and 1 after eribulin. Adverse events associated with Grade 3 IRRs included chills, fever, nausea, diarrhea, dyspnea, and/or hypertension. Two patients receiving M (0.8%) discontinued due to IRR, versus none on T. Of patients with IRRs, the most common symptoms in both treatment groups were chills (M: 17 [48.6%]; T: 5 [55.6%]) and fever (M: 13 [37.1%]; T: 2 [22.2%]). There was no observed hypotension in either group. In both groups, more than half of IRR events were addressed by dose interruption only. All IRRs all were medically manageable. IRR rates were higher in patients without premedication for both groups. Of 264 subjects receiving M, 218 (82.6%) received premedication and 46 (17.4%) did not; IRRs were observed in 28 (12.8%) of those receiving premedication and 7 (15.2%) of those not premedicated. All 4 patients on M with Grade 3 IRRs received premedication, 3 with steroids. Of 266 subjects receiving T, 173 (65%) received premedication and 93 (35%) did not; IRRs were observed in 5 (2.9%) of those receiving premedication and 4 (4.3%) of those not premedicated. IRR risk was unaffected by chemotherapy subgroup or CD16A genotype. sljwpbfqzt (ehpatjabvy )
Positive
15 Feb 2021
Trastuzumab + Chemotherapy
Phase 3
536
Margetuximab 15 mg/kg Q3W
vqsdzoytkz(ifdamxlore) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days yzvervmyjf (fuihucjsyf )
Positive
15 Feb 2021
Other doses of Margetuximab (0.1 - 18 mg/kg)
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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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