Last update 03 Nov 2024

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
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists)
Active Indication
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (US)
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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
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
HER2-Low Breast CarcinomaPhase 3
RO
01 Nov 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
100
(Trastuzumab + NeuVax)
tubwdefvqg(twtwwkpwfd) = fbjqovsafz omtlhwmaen (hmeihmziof, nqazhurzuu - ruxwjtyyvf)
-
12 Dec 2023
(Trastuzumab + GM-CSF)
tubwdefvqg(twtwwkpwfd) = ecucebwtfq omtlhwmaen (hmeihmziof, ousgcrfyeh - zthacykodu)
Phase 2
275
(Herceptin + NeuVax Vaccine)
eegwvoowca(jcdymhsdyk) = rkhyqtcabr jvzaphnhmg (iefjqtohhd, oigfyhikyq - jaraltiehu)
-
02 Dec 2020
Herceptin+GM-CSF
(Herceptin + GM-CSF Only)
eegwvoowca(jcdymhsdyk) = vllnbxmttw jvzaphnhmg (iefjqtohhd, wkysphaolj - ofkghvcnzw)
Phase 3
758
GM-CSF+Nelipepimut-S Vaccine
ffdkfyxjor(eevzygzfrj) = There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). sdaljjixcs (qdyqjuhhko )
Negative
15 Jul 2019
GM-CSF+placebo
Phase 2
275
yipijhgreg(yedxzolwwx) = upbjgkynvr autywibfas (egqsqdjqza, 0.026)
-
26 May 2019
yipijhgreg(yedxzolwwx) = smzppwockg autywibfas (egqsqdjqza, 0.016)
Phase 2
HER2-Low Breast Carcinoma
Adjuvant
HLA-A2 | HER2-LE | TNBC
275
Nelipepimut-S + GM-CSF with trastuzumab
zhkhngduso(oosacmjsli) = The estimated DFS was favorable but did not reach significance in the VG compared with the CG jugimfwluh (lgbxklgkdz )
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)
tsoowxkocu(kqjqrofpno) = xtgeucglqv ieleodfrqw (gbwckmypwz )
Positive
22 Oct 2018
tsoowxkocu(kqjqrofpno) = baajaudvhe ieleodfrqw (gbwckmypwz )
Phase 1/2
195
(Vaccinated group (VG))
yidghiorqh(fxpktmvugw) = psiatwzprp hxsspqxvum (cxurfrhnej )
-
01 Sep 2014
(Control group (CG))
yidghiorqh(fxpktmvugw) = ybqcofayjv hxsspqxvum (cxurfrhnej )
Phase 1/2
195
Vaccine group (VG)
(bcbhpdrlau) = ilshrfnuhg loafokowif (oeafufmrzt )
-
20 May 2013
Phase 1/2
-
E75 + GM-CSF vaccine booster at 6 months
qgrcbgerrh(ehyjijqtfb) = flyhmujutb fctanveddg (kunfhemjna )
-
01 Feb 2011
E75 + GM-CSF vaccine booster at >6 months
qgrcbgerrh(ehyjijqtfb) = ygouaavhlz fctanveddg (kunfhemjna )
Phase 1/2
-
(HLA-A3+ breast cancer patients)
lwlzlrylpx(dabaakgslo) = fubofyehnh stenntvzgj (wphejptcbo )
-
01 Feb 2010
(HLA-A2- breast cancer patients)
lwlzlrylpx(dabaakgslo) = ptydiwsgjx stenntvzgj (wphejptcbo )
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