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    DRUG:

    feladilimab (GSK3359609)

    i
    Other names: GSK3359609, GSK 3359609, GSK-3359609, inducible T-cell co-stimulator, GSK609
    Company:
    GSK
    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
    |
    ICOS (Inducible T Cell Costimulator) • CD40 (CD40 Molecule)
    |
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • feladilimab (GSK3359609)
    3ms
    DREAMM 5: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P2, N=208, Active, not recruiting, GlaxoSmithKline | Trial completion date: Feb 2029 --> Mar 2027 | Trial primary completion date: Feb 2029 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    lenalidomide • Jemperli (dostarlimab-gxly) • dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    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
    |
    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
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    feladilimab (GSK3359609)
    8ms
    CD28 and ICOS in immune regulation: Structural insights and therapeutic targeting. (PubMed, Bioorg Med Chem Lett)
    Key therapeutic approaches include CTLA-4-Ig fusion proteins (abatacept, belatacept) for autoimmune diseases, ICOS agonists (feladilimab, vopratelimab) to enhance anti-tumor immunity, and bispecific CD28-engaging antibodies (CD28xCD3, CD28xPSMA) for cancer immunotherapy. By integrating structural insights with translational drug development, this review provides a framework for optimizing CD28- and ICOS-targeted therapies. Further advancements in biologics, peptide-based inhibitors, and immune checkpoint modulation will enhance the precision and efficacy of immunotherapeutic strategies.
    Review • Journal
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • ICOS (Inducible T Cell Costimulator)
    |
    feladilimab (GSK3359609) • vopratelimab (JTX-2011)
    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
    |
    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
    |
    Yervoy (ipilimumab) • feladilimab (GSK3359609)
    1year
    DREAMM 5: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P2, N=209, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P2 | N=464 --> 209 | Trial primary completion date: Feb 2026 --> Feb 2029
    Enrollment closed • Phase classification • Enrollment change • Trial primary completion date
    |
    lenalidomide • Jemperli (dostarlimab-gxly) • dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    1year
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=176, Completed, GlaxoSmithKline | Recruiting --> Completed | Trial completion date: Jul 2025 --> May 2024 | Trial primary completion date: Jul 2025 --> May 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Yervoy (ipilimumab) • docetaxel • Jemperli (dostarlimab-gxly) • feladilimab (GSK3359609) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • feladilimab (GSK3359609)