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    DRUG CLASS:

    ICOS agonist

    Related drugs:
    2d
    First-in-human, phase 1, open-label study of alomfilimab, an anti-ICOS antibody, as a single agent and in combination with anti-PD-L1 in advanced malignancies. (PubMed, J Immunother Cancer)
    Alomfilimab treatment was associated with an acceptable safety profile across both mono and combination approaches, accompanied by decreased ICOS+Tregs populations and enhanced CD4+ and CD8+ effector T cells cell activity. Limited clinical activity was observed despite evidence of biological activity.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker • First-in-human
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    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)
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    Tecentriq (atezolizumab) • alomfilimab (SAR445256)
    29d
    ENTRÉE Lung Platform Trial Sub-study 1: Phase II Randomized Efficacy and Safety Analysis of Feladilimab Plus Docetaxel Versus Docetaxel Monotherapy in Advanced/Recurrent NSCLC. (PubMed, Clin Lung Cancer)
    Feladilimab plus docetaxel has an acceptable safety profile in the second-line treatment of advanced/recurrent NSCLC. No survival outcomes or tumor response advantages were observed with the addition of feladilimab to docetaxel in this setting.
    P2 data • Journal • IO biomarker
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    ICOS (Inducible T Cell Costimulator)
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    docetaxel • feladilimab (GSK3359609)
    4ms
    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)
    |
    feladilimab (GSK3359609) • vopratelimab (JTX-2011)
    6ms
    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)
    8ms
    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
    |
    Blenrep (belantamab mafodotin-blmf) • feladilimab (GSK3359609)
    10ms
    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
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    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 | Initiation date: Jan 2019 --> Mar 2021
    Trial initiation date
    |
    Yervoy (ipilimumab) • feladilimab (GSK3359609)
    over1year
    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
    |
    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)
    |
    PD-L1 expression
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    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • feladilimab (GSK3359609)
    almost2years
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • feladilimab (GSK3359609)
    2years
    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
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vopratelimab (JTX-2011)