^
    10d
    First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=141, Recruiting, GlaxoSmithKline | Trial completion date: Oct 2026 --> Sep 2028 | Trial primary completion date: Oct 2026 --> Sep 2028
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • GSK5764227 • nelistotug (GSK6097608)
    10d
    GALAXIES LUNG-201: A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
    P2, N=340, Recruiting, GlaxoSmithKline | Trial completion date: Jan 2028 --> Oct 2028 | Trial primary completion date: Jan 2025 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    25d
    Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=16, Terminated, iTeos Therapeutics | Phase classification: P1/2 --> P1
    Phase classification • Combination therapy
    |
    dexamethasone • iberdomide (CC-220) • belrestotug (EOS-448)
    2ms
    First-In-Human Study of EOS884448 in Participants with Advanced Cancers. (clinicaltrials.gov)
    P1, N=40, Completed, iTeos Therapeutics | Phase classification: P1/2 --> P1
    Phase classification
    |
    belrestotug (EOS-448)
    4ms
    A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202 (clinicaltrials.gov)
    P2, N=360, Recruiting, GlaxoSmithKline | Trial completion date: Aug 2027 --> May 2027 | Trial primary completion date: Sep 2025 --> May 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    4ms
    Interim analysis of GALAXIES Lung-201: Phase II, randomized, open-label platform study of belrestotug plus dostarlimab in patients (pts) with previously untreated locally advanced/metastatic (LA/M) PD-L1 high (TPS >/=50%) non-small cell lung cancer (NSCLC) (ESMO 2024)
    At this IA, belrestotug + dostarlimab demonstrated clinically meaningful anti-tumor activity at each dose and a manageable safety profile, supporting further evaluation in pts with previously untreated, unresectable LA/M PD-L1 high NSCLC. 1. Reck M, et al.
    Late-breaking abstract • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Jemperli (dostarlimab-gxly) • belrestotug (EOS-448)
    5ms
    Acute Eosinophilic Pneumonia Induced by Immune Checkpoint Inhibitor and Anti-TIGIT Therapy. (PubMed, Am J Case Rep)
    She was participating in a clinical trial using pembrolizumab and anti-TIGIT EOS-448, due to cancer progression...She was then empirically started on intravenous methylprednisolone for acute eosinophilic pneumonia without confirmatory bronchoscopy as she was at high risk with her previous pneumonectomy...Although bronchoscopy findings are part of AEP's diagnostic criteria, this case underscores the importance of clinical judgment in the prompt initiation of steroids, even without confirmatory bronchoscopy, in rapidly progressing cases. The role of anti-TIGIT therapy in this context remains uncertain.
    Journal • Checkpoint inhibition
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Keytruda (pembrolizumab) • belrestotug (EOS-448) • methylprednisolone sodium succinate
    5ms
    A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=1000, Recruiting, GlaxoSmithKline
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448)
    5ms
    TIG-006: Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=153, Active, not recruiting, iTeos Belgium SA | Recruiting --> Active, not recruiting | N=254 --> 153 | Trial completion date: Jan 2025 --> Jul 2025
    Enrollment closed • Enrollment change • Trial completion date • Combination therapy • Pan tumor • Metastases
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • inupadenant (EOS-850)
    8ms
    Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=16, Terminated, iTeos Belgium SA | N=162 --> 16 | Trial completion date: Dec 2025 --> Nov 2023 | Recruiting --> Terminated; Company operational decision. Decision to stop study is not due to safety or efficacy concerns
    Enrollment change • Trial completion date • Trial termination • Combination therapy
    |
    dexamethasone • iberdomide (CC-220) • belrestotug (EOS-448)
    11ms
    TIG-006: Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=254, Recruiting, iTeos Belgium SA | N=376 --> 254 | Trial completion date: Sep 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Sep 2024
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Pan tumor • Metastases
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • inupadenant (EOS-850)
    1year
    A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
    P2, N=300, Recruiting, GlaxoSmithKline | Trial completion date: Mar 2026 --> Jan 2028
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    1year
    Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=244, Recruiting, GlaxoSmithKline | N=184 --> 244 | Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Jul 2024 --> Sep 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    1year
    A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov)
    P2, N=300, Recruiting, GlaxoSmithKline | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Oct 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    over1year
    Study Design to Assess Anti-TIGIT Mab Combination with Dostarlimab vs Pembrolizumab or Dostarlimab Monotherapy in NSCLC (IASLC-WCLC 2023)
    Introduction: Immune checkpoint blockade has revolutionized the therapeutic approach to non-small cell lung cancer (NSCLC), though not all patients benefit and some develop resistance, necessitating new approaches. Secondary endpoints include PFS, overall survival, duration of response, safety measures, anti-drug antibodies, and pharmacokinetics of GSK4428859A and dostarlimab. Enrollment began on October 14, 2022, and is ongoing.
    PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • CD96 (CD96 Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
    |
    PD-L1 expression • EGFR mutation • PD-L1 overexpression • ALK translocation
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448)
    over1year
    Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1 | N=184 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Apr 2025 ➔ Jul 2024 | Trial primary completion date: Apr 2025 ➔ Jul 2024
    Combination therapy • Trial completion date • Trial primary completion date
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    2years
    Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=300, Recruiting, GlaxoSmithKline | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1-H
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448)
    2years
    Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=300, Not yet recruiting, GlaxoSmithKline
    New P2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1-H
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448)
    2years
    Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants with Previously Untreated Advanced/Metastatic NonSmallCell Lung Cancer (clinicaltrialsregister.eu)
    P2, N=300, Ongoing, GlaxoSmithKline Research & Development Limited
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1-H
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448)
    over2years
    Phase II study of anti-TIGIT GSK4428859A (GSK'859A)/EOS-448 + anti-CD96 GSK6097608 (GSK'608) + anti-PD-1 dostarlimab in non-small cell lung cancer (NSCLC) (ESMO 2022)
    Patients will receive IV GSK'859A/EOS-448 + dostarlimab + GSK'608 (dose escalation) q3w for ≤35 cycles or 2 years or until disease progression, consent withdrawal, intolerability, or death. Part 1 endpoints are safety and tolerability (primary) and efficacy and pharmacokinetics (secondary).
    P2 data
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • CD96 (CD96 Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
    |
    Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    over2years
    Phase 2 Platform Trial of Anti-TIGIT GSK’859A/EOS-448 + Anti-PD-1 Dostarlimab in Non-small Cell Lung Cancer (NSCLC) (IASLC-WCLC 2022)
    Patients who received prior docetaxel or have known molecular alterations with therapeutic options available (eg, EGFR, ALK, ROS1) are excluded. Part 1 primary endpoints are safety and tolerability, and secondary endpoints are efficacy and pharmacokinetics. Four patients have been treated at the starting dose (Figure) as of March 1, 2022.
    P2 data
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
    |
    docetaxel • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448)
    over2years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=185, Recruiting, GlaxoSmithKline | N=140 --> 185 | Trial completion date: Jun 2024 --> Jul 2025 | Trial primary completion date: Jun 2024 --> Jul 2025
    Enrollment change • 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)
    over2years
    Pharmacodynamic assessment of a-TIGIT mAb EOS-448 highlights multiple FcγR-mediated mode-of-actions in blood and tumor of patients with advanced solid tumors (AACR 2022)
    5.Guo X et al. Nat Medicine ; 2018.
    Clinical • PK/PD data • Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • FOXP3 (Forkhead Box P3)
    |
    CD8 expression • CD8-H
    |
    belrestotug (EOS-448)
    3years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=140, Recruiting, GlaxoSmithKline | N=341 --> 140 | Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Mar 2025 --> Jun 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Yervoy (ipilimumab) • docetaxel • Jemperli (dostarlimab-gxly) • feladilimab (GSK3359609) • belrestotug (EOS-448)
    3years
    TIG-007: Study of EOS884448/GSK4428859A Alone, and in Combination with Iberdomide with or without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma (ASH 2021)
    Minimal residual disease (MRD) status with therapy will also be assessed as clinically indicated. The study is planned to open in November 2021 in North America and Europe.
    Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • CRBN (Cereblon) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    dexamethasone • iberdomide (CC-220) • belrestotug (EOS-448)
    3years
    TIG-006: Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=276, Recruiting, iTeos Belgium SA
    Clinical • New P1/2 trial • Combination therapy • Pan tumor
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • belrestotug (EOS-448) • inupadenant (EOS-850)
    over4years
    [VIRTUAL] Preparation of aclinical trial with a-TIGIT antagonist antibody EOS884448, which demonstrates potent preclinical activity and safe toxicology profile (AACR-II 2020)
    CD155 expression analysed by IHC in solid cancers (n=284) was higher in tumor and seen in the nine tested indications, with close to 50% of CD155high tumor cells measured in indications including pancreatic, prostate, kidney, gastric and colon cancers. CD226 expression was confirmed by IHC on immune infiltrate in solid tumor samples (n=307).Altogether, preclinical, toxicology and translational medicine data support the initiation of a FIH study of a-TIGIT mAb EOS884448 in cancer patients.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
    |
    belrestotug (EOS-448)