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Research Report
Belrestotug (EOS-448): A Clinical and Scientific Post-Mortem of a Terminated Anti-TIGIT Immunotherapy
Section 1: Executive Summary
Belrestotug, also identified by its development codes EOS-448 and GSK4428859A, is a human immunoglobulin G1 ($IgG1$) monoclonal antibody developed to target the T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT).[1] Co-developed by iTeos Therapeutics and GlaxoSmithKline (GSK), Belrestotug was positioned as a next-generation immuno-oncology therapeutic designed to enhance anti-tumor immunity, particularly in patients with cancers resistant to existing programmed death receptor-1 (PD-1) or its ligand (PD-L1) inhibitors.[4]
The clinical development strategy for Belrestotug centered on its combination with dostarlimab (Jemperli), an anti-PD-1 antibody, in first-line treatment settings for cancers with high PD-L1 expression.[6] The primary target indications were non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) of $\ge50\%$ and head and neck squamous cell carcinoma (HNSCC) with a PD-L1 combined positive score (CPS) of $\ge1$.[8] This strategy was predicated on the hypothesis that dual blockade of the TIGIT and PD-1 pathways would produce synergistic anti-tumor effects and overcome mechanisms of immune escape.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/24 | Phase 3 | Active, not recruiting | |||
2023/10/02 | Phase 2 | Active, not recruiting | |||
2022/10/04 | Phase 2 | Active, not recruiting | |||
2022/03/21 | Phase 1 | Terminated | |||
2022/03/14 | Phase 1 | Recruiting | |||
2021/09/29 | Phase 1 | Active, not recruiting | |||
2020/06/24 | Phase 1 | Active, not recruiting | |||
2020/04/06 | Phase 1 | Completed | |||
2018/11/14 | Phase 2 | Completed |
FDA Drug Approvals
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EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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