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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
pemlimogene merolisbac (JNJ-64041757)
i
Other names: JNJ-64041757, bivalent Listeria-based immunotherapy, ADU-214, JNJ-757, ADU214, ADU 214
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News alerts, weekly reports and conference planners
Company:
Novartis
Drug class:
EGFR inhibitor, Mesothelin inhibitor
Related drugs:
3years
JNJ-64041757 (JNJ-757), a Live, Attenuated, Double-Deleted Listeria monocytogenes-Based Immunotherapy in Patients With NSCLC: Results From Two Phase 1 Studies. (PubMed, JTO Clin Res Rep)
As monotherapy, JNJ-757 was immunogenic and tolerable, with mild infusion-related fever and chills. The limited efficacy of JNJ-757, alone or with nivolumab, did not warrant further investigation of the combination.
Clinical • P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
|
MSLN (Mesothelin)
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MSLN expression
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Opdivo (nivolumab) • pemlimogene merolisbac (JNJ-64041757)
6years
Safety & Immunogenicity of JNJ-64041757, Live-attenuated Double-deleted Listeria Immunotherapy, in Subjects With Non Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=18, Terminated, Janssen Research & Development, LLC | Trial completion date: Mar 2020 --> Oct 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2020 --> Aug 2018; Development of JNJ-64041757 discontinued due to lack of efficacy. No further follow up data will be collected after October 22, 2018.
Clinical • Trial completion date • Trial termination • Trial primary completion date • IO biomarker
|
ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4) • MSLN (Mesothelin)
|
ALK rearrangement • MSLN overexpression
|
pemlimogene merolisbac (JNJ-64041757)
6years
An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung (clinicaltrials.gov)
P1b/2; N=12; Terminated; Sponsor: Janssen Research & Development, LLC; Trial completion date: Nov 2020 --> Oct 2018; Active, not recruiting --> Terminated; Trial primary completion date: Oct 2020 --> Oct 2018; Development of JNJ-64041757 in combination with nivolumab discontinued due to lack of clinical benefit observed in the Phase 1b portion of the study
Trial completion date • Trial primary completion date • Trial termination
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PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
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Opdivo (nivolumab) • pemlimogene merolisbac (JNJ-64041757)
6years
An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung (clinicaltrials.gov)
P1b/2; N=12; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting --> Active, not recruiting; N=170 --> 12; Trial completion date: Mar 2022 --> Nov 2020
Trial completion date • Enrollment change • Enrollment closed
|
PD-L1 (Programmed death ligand 1) • MSLN (Mesothelin)
|
Opdivo (nivolumab) • pemlimogene merolisbac (JNJ-64041757)
over6years
Safety & Immunogenicity of JNJ-64041757, Live-attenuated Double-deleted Listeria Immunotherapy, in Subjects With Non Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=18, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | N=42 --> 18
Clinical • Enrollment closed • Enrollment change • IO biomarker
|
ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4) • MSLN (Mesothelin)
|
ALK rearrangement • MSLN overexpression
|
pemlimogene merolisbac (JNJ-64041757)
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