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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:
    28d
    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) • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    2ms
    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)
    4ms
    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)
    6ms
    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)
    6ms
    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)
    11ms
    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)
    11ms
    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) • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    12ms
    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)
    1year
    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)
    2years
    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)
    P1/2, N=464, Recruiting, GlaxoSmithKline | Trial completion date: Feb 2028 --> Feb 2029 | Trial primary completion date: Feb 2025 --> Feb 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • Jemperli (dostarlimab-gxly) • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    2years
    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)
    P2/3, N=118, Terminated, GlaxoSmithKline | Active, not recruiting --> Terminated; The trial was stopped by the sponsor based on assessment of the clinical data
    Trial termination • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • feladilimab (GSK3359609)