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    DRUG CLASS:

    ICOS agonist

    Related drugs:
    5d
    Advancing ICOS agonism in solid tumors: lessons from INDUCE-1. (PubMed, J Immunother Cancer)
    Although feladilimab demonstrated favorable safety and robust receptor occupancy, clinical responses were limited-echoing similar experiences with vopratelimab (JTX-2011) and other ICOS agonists. These outcomes highlight that effective ICOS modulation depends not only on receptor engagement but also on spatial and temporal regulation of effector versus regulatory T-cell responses. Future ICOS-directed strategies, whether agonistic or antagonistic, monoclonal or bispecific, will require rational combination approaches and biomarker-driven patient selection to fully harness this pathway's therapeutic potential.
    Review • Journal • IO biomarker
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    ICOS (Inducible T Cell Costimulator) • CD40 (CD40 Molecule)
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    feladilimab (GSK3359609) • vopratelimab (JTX-2011)
    1m
    INDUCE-3: A randomized Phase II/III study of first-line feladilimab plus pembrolizumab in patients with recurrent/metastatic head and neck squamous cell carcinoma. (PubMed, Clin Cancer Res)
    This analysis does not support the combination of feladilimab plus pembrolizumab due to lack of superiority over placebo plus pembrolizumab.
    Clinical • P2/3 data • Journal
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    PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • feladilimab (GSK3359609)
    4ms
    Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM (clinicaltrials.gov)
    P1/2, N=25, Active, not recruiting, GlaxoSmithKline
    New P1/2 trial
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    Blenrep (belantamab mafodotin-blmf) • feladilimab (GSK3359609)
    6ms
    First-in-human phase 1 study of the ICOS agonist feladilimab on patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    This study showed the feasibility of a modified Toxicity Proportion Interval design and PK/PD analysis to determine a recommended dose for a compound without a dose-limiting toxicity and a tolerable and manageable safety profile.
    P1 data • Journal • IO biomarker
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    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
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    feladilimab (GSK3359609)
    8ms
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2 (clinicaltrials.gov)
    P2, N=8, Terminated, GlaxoSmithKline | Initiation date: Jan 2019 --> Mar 2021
    Trial initiation date
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    Yervoy (ipilimumab) • feladilimab (GSK3359609)
    1year
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2 (clinicaltrials.gov)
    P2, N=8, Terminated, GlaxoSmithKline
    New P2 trial
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    Yervoy (ipilimumab) • feladilimab (GSK3359609)
    over1year
    Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer (clinicaltrials.gov)
    P1/2, N=222, Terminated, Kymab Limited | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
    Trial termination • Combination therapy • Metastases
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    Tecentriq (atezolizumab) • alomfilimab (SAR445256)
    over1year
    INDUCE-4: Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=117, Terminated, GlaxoSmithKline | Phase classification: P2/3 --> P3
    Phase classification
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • feladilimab (GSK3359609)
    over1year
    INDUCE-3: Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=315, Terminated, GlaxoSmithKline | Phase classification: P2/3 --> P3
    Phase classification • Combination therapy • IO biomarker • Metastases
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    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • feladilimab (GSK3359609)
    over1year
    Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=4, Terminated, Jounce Therapeutics, Inc. | Completed --> Terminated; Sponsor decision to discontinue providing study drug to patients who have been on study treatment for more than two years
    Trial termination • Combination therapy • Metastases
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • vopratelimab (JTX-2011)
    over1year
    Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov)
    P2, N=69, Terminated, Jounce Therapeutics, Inc. | Active, not recruiting --> Terminated; The Sponsor decided to discontinue development of pimivalimab prior to the planned study completion. At the time of the decision to discontinue development, enrollment in the study had been completed.
    Trial termination
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    pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    almost2years
    Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer (clinicaltrials.gov)
    P1/2, N=280, Active, not recruiting, Kymab Limited | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
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    Tecentriq (atezolizumab) • alomfilimab (SAR445256)