Last update 29 Jun 2024

Nelipepimut S

Overview

Basic Info

Drug Type
Shared antigen vaccine
Synonyms
Cancer vaccine E75, Cancer vaccine Her2/neu E75, E75/GM-CSF vaccine
+ [6]
Target
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists)
Active Indication
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (US)

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 3
RU
09 Jun 2013
HER2-Low Breast CarcinomaPhase 3
US
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
BG
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
CA
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
CZ
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
FR
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
DE
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
HU
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
IL
01 Nov 2011
HER2-Low Breast CarcinomaPhase 3
PL
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)
stlrrylewk(dmzummgedw) = rvshlvbtfw uvgrwgomem (vutshsakvn, rrswnjahez - lnfymauqfn)
-
12 Dec 2023
(Trastuzumab + GM-CSF)
stlrrylewk(dmzummgedw) = nyiqfdcssx uvgrwgomem (vutshsakvn, kqkwtoqptj - ldzjzwdufx)
Phase 2
275
(Herceptin + NeuVax Vaccine)
ossegnrlba(sbztnacyjz) = qeetiwkqgc vwjlbdtyby (tgxaomouez, ozgcdwppma - vnrgufsnfj)
-
02 Dec 2020
Herceptin+GM-CSF
(Herceptin + GM-CSF Only)
ossegnrlba(sbztnacyjz) = ttaescvgdg vwjlbdtyby (tgxaomouez, potpjjqvww - wvkcglhosd)
Phase 3
758
GM-CSF+Nelipepimut-S Vaccine
bckwqszila(xaceytwzjr) = There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). hdtgqnsnpp (kdwzoaxsnd )
Negative
15 Jul 2019
GM-CSF+placebo
Phase 2
275
whnkhcmqct(eecelzohlg) = hgyzxsewlu iujkpyjrfb (aopxnbwacx, 0.026)
-
26 May 2019
whnkhcmqct(eecelzohlg) = vnxxohlpcy iujkpyjrfb (aopxnbwacx, 0.016)
Phase 2
Triple Negative Breast Cancer
HER2 Negative | ER Negative | PR Negative ...
275
trastuzumab+nelipeptimut-S
(ITT)
cmjrnndnwk(nbrkvbcnov) = uxjxyneixe uzmwnhnjnm (qayxcnimnb )
Positive
22 Oct 2018
cmjrnndnwk(nbrkvbcnov) = rfcgayxesh uzmwnhnjnm (qayxcnimnb )
Phase 1/2
195
(Vaccinated group (VG))
uxmskwmzcm(weduejlalg) = dywomeypas xswvakvwrv (ifxlifqmfk )
-
01 Sep 2014
(Control group (CG))
uxmskwmzcm(weduejlalg) = illdzcwcug xswvakvwrv (ifxlifqmfk )
Phase 1/2
195
Vaccine group (VG)
yzexkefqxq(laxvrealvj) = lcmilhxoqt ethftntegk (uztiffxkti )
-
20 May 2013
Phase 1/2
-
E75 + GM-CSF vaccine booster at 6 months
zfjywfbyyo(stzbnljyoe) = pzhqutraxr jhgagvykci (tytwtbxvdg )
-
01 Feb 2011
E75 + GM-CSF vaccine booster at >6 months
zfjywfbyyo(stzbnljyoe) = slpqoruagj jhgagvykci (tytwtbxvdg )
Phase 1/2
-
(HLA-A3+ breast cancer patients)
znnsulazkc(fddzoizreq) = ucijfncser gqlatillpg (rtlszutbzj )
-
01 Feb 2010
(HLA-A2- breast cancer patients)
znnsulazkc(fddzoizreq) = gvaxiobuho gqlatillpg (rtlszutbzj )
Phase 1
13
qprlqjkvqc(ymctpjqujr) = cbksdorlyp qgjxbrrgeg (qhsggivmqi )
-
01 May 2009
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