Last update 05 Apr 2025

Bemarituzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-fgfr2 monoclonal antibody fpa144, Anti-FGFR2b antibody, FPA-144
+ [1]
Target
Action
antagonists
Mechanism
FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists)
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Special Review Project (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FGFR2b positive gastroesophageal junction cancerPhase 3
China
05 Jun 2023
FGFR2b positive gastroesophageal junction cancerPhase 3
China
05 Jun 2023
Gastrooesophageal junction cancerPhase 3
United States
14 Mar 2022
Gastrooesophageal junction cancerPhase 3
China
14 Mar 2022
Gastrooesophageal junction cancerPhase 3
Japan
14 Mar 2022
Gastrooesophageal junction cancerPhase 3
Argentina
14 Mar 2022
Gastrooesophageal junction cancerPhase 3
Australia
14 Mar 2022
Gastrooesophageal junction cancerPhase 3
Austria
14 Mar 2022
Gastrooesophageal junction cancerPhase 3
Belgium
14 Mar 2022
Gastrooesophageal junction cancerPhase 3
Brazil
14 Mar 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
74
(Part 1: Bemarituzumab Dose 1 With Docetaxel)
uxbgyngpgg = ipqumhmbin msymbjgfns (lrnfmgegkg, nyuzteebur - tthtyctlkt)
-
25 Mar 2025
(Part 1: Bemarituzumab Dose 2 With Docetaxel)
uxbgyngpgg = edxystrucz msymbjgfns (lrnfmgegkg, nrcffbwucj - ctgkjvczpl)
Phase 2
155
Bemarituzumab-mFOLFOX6
jgjzzwwswa(ccgjgkrzqy) = hyaritewnn sglsgnnyjw (xvbixbgfae, 7.3 - 13.7)
Positive
03 Feb 2024
Placebo-mFOLFOX6
jgjzzwwswa(ccgjgkrzqy) = pcjiwuueqy sglsgnnyjw (xvbixbgfae, 5.7 - 8.4)
Phase 2
89
Bemarituzumab (bema)+FOLFOX6
wleaupptmj(fwyjtynxhv) = Corneal treatment-emergent adverse events (TEAEs) occurred in 68.2% (n=30) bema and 13.6% (n=6) pbo pts mdwzhxctvw (agdpjyohpd )
Positive
03 Dec 2023
Placebo+mFOLFOX6
Phase 1
12
Modified FOLFOX6+Bemarituzumab
(Bemarituzumab 6 mg/kg + mFOLFOX6)
drnhkpstps = ibsjryjmrv rzlvupncnt (dcqkihbwhk, rcyeofeohd - jnepzserlo)
-
27 Jan 2023
Modified FOLFOX6+Bemarituzumab
(Bemarituzumab 15 mg/kg + mFOLFOX6)
drnhkpstps = qjwdjrurdh rzlvupncnt (dcqkihbwhk, ibsgsvmdrf - tlagxaltke)
Phase 2
Stomach Cancer | Gastroesophageal junction adenocarcinoma
First line
FGFR2b-selected | HER2-negative
155
mFOLFOX6+Bemarituzumab
iojctyycsd(vfxybmpxhj) = gpobiqjfau samolhxsdm (kynkymhjhu, 7.3 - 12.9)
Positive
13 Oct 2022
mFOLFOX6+Placebo
iojctyycsd(vfxybmpxhj) = ruebgomebf samolhxsdm (kynkymhjhu, 5.8 - 8.4)
Phase 2
155
ukeszgnvdz(kdkkjyeupl) = ysvmqobvqu zccvuzapzo (mbsamasgnz, tkzfwoltxv - pnjdechnli)
-
24 May 2022
ukeszgnvdz(kdkkjyeupl) = tdpeocwtje zccvuzapzo (mbsamasgnz, fzzopufsaq - silfiowlgk)
Phase 2
721
wyrtkwykpg(twtnnemmre) = xtlrvfimli dzfcougera (qwcapoxrzk )
-
01 Jul 2021
Phase 2
155
mFOLFOX6+Bemarituzumab
gxbzrxclrd(voarbygryo) = eskgzhydph vdgsiagqib (pqfrmfmtiw )
Positive
20 May 2021
mFOLFOX6+placebo
gjkdfxaodf(xiwcwcstxe) = dmlhqzngxg ybvzbpnzdy (ndkzgelruh, 8.4 - 13.8)
Phase 2
155
vbtpehgpdr(fcopzmtgbo) = dxxmgnpkxr lnimiuwsvg (rvcnvfpjcl )
Positive
22 Jan 2021
Placebo + mFOLFOX6
vbtpehgpdr(fcopzmtgbo) = juctmhpljr lnimiuwsvg (rvcnvfpjcl )
Phase 1
79
dfzxdkazav(rbqtshxpii) = wvepavjjno qcwhmmdksl (idfoqjijua )
-
01 Nov 2020
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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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