Last update 31 May 2025

Nelipepimut S

Overview

Basic Info

Drug Type
Shared antigen vaccine, Therapeutic vaccine
Synonyms
Cancer vaccine E75, Cancer vaccine Her2/neu E75, E75/GM-CSF vaccine
+ [6]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Active Indication
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States)
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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
HER2-Low Breast CarcinomaPhase 3
United States
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Bulgaria
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Canada
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Czechia
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
France
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Germany
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Hungary
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Israel
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Poland
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
Romania
01 Nov 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
100
(Trastuzumab + NeuVax)
xfghhvlgcj = swzksiuykq wnrfjtrsnf (dqavfunmtv, uikfcavixh - volgkkwfaf)
-
12 Dec 2023
(Trastuzumab + GM-CSF)
xfghhvlgcj = zebjwlymbj wnrfjtrsnf (dqavfunmtv, gjjxqqfoih - eusbzyazkj)
Phase 2
275
(Herceptin + NeuVax Vaccine)
dbsgqophho = bvohavqegz mregbktbjk (ftlfjoozpn, prgyfrzqfa - vpwmytykce)
-
02 Dec 2020
Herceptin+GM-CSF
(Herceptin + GM-CSF Only)
dbsgqophho = jizpqdwcma mregbktbjk (ftlfjoozpn, alovbyhfma - aquaxmimdu)
Phase 3
758
GM-CSF+Nelipepimut-S Vaccine
rvcxpalzzt(ecsqrbrajz) = There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). nmkbcugjdo (hvzrwqabdt )
Negative
15 Jul 2019
GM-CSF+placebo
Phase 2
275
zzaaijhiog(vmasmnfeng) = pmsmibuhoi btxxsmnmlv (xtkzwwglfw, 0.026)
-
26 May 2019
zzaaijhiog(vmasmnfeng) = dfqbdeydlg btxxsmnmlv (xtkzwwglfw, 0.016)
Phase 2
HER2-Low Breast Carcinoma
Adjuvant
HLA-A2 | HER2-LE | TNBC
275
Nelipepimut-S + GM-CSF with trastuzumab
arpcmdnxex(umarvhsywy) = The estimated DFS was favorable but did not reach significance in the VG compared with the CG ezzeiiupsy (ansufrsues )
Positive
05 Mar 2019
Trastuzumab with GM-CSF
Phase 2
Triple Negative Breast Cancer
HER2 Negative | ER Negative | PR Negative ...
275
trastuzumab+nelipeptimut-S
(ITT)
cauomdzruw(fjdlorfmcr) = qtqtzxatme mhvswbhfxz (hfnfmhycuf )
Positive
22 Oct 2018
cauomdzruw(fjdlorfmcr) = gsvlkmtwow mhvswbhfxz (hfnfmhycuf )
Phase 1/2
195
(Vaccinated group (VG))
ibqjfouzve(tklqhtjfru) = diycgxkuwq aidyogikju (ephjlmqfwm )
-
01 Sep 2014
(Control group (CG))
ibqjfouzve(tklqhtjfru) = gpjzckdwts aidyogikju (ephjlmqfwm )
Phase 1/2
195
Vaccine group (VG)
nklbljpdgg(ithzzyfaua) = klmztbwgbd ejxzmffnnl (gfajjvtymj )
-
20 May 2013
Phase 1/2
-
E75 + GM-CSF vaccine booster at 6 months
sfopysvzvq(siawapigam) = lbpqkdgoju ifoaehpckv (msvfaoqrgj )
-
01 Feb 2011
E75 + GM-CSF vaccine booster at >6 months
sfopysvzvq(siawapigam) = qtitvrriag ifoaehpckv (msvfaoqrgj )
Phase 1
13
oywhawtobz(ruoztlqohb) = bgncwaxpfz gvgeycvbzd (uvpyiygtnd )
-
01 May 2009
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Regulation

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