GSK Terminates TIGIT Monoclonal Antibody Belrestotug Development, $625M Upfront Payment Lost

May 14, 2025 11:01 CST Updated 11:01

GSK

Pharmaceutical R&D Manufacturer

iTeos Therapeutics

Developer of Immuno-Oncology Therapeutics

On May 13 local time, GSK announced with its partneriTeos Therapeutics has confirmed thatTerminationDevelopment Plan for TIGIT Monoclonal Antibody Belrestotug。

Screenshot source: Corporate official website

The decision was based onGALAXIES Lung-201 and GALAXIES H&N-202Failed to meet the established efficacy criteria for continued development。

GSK's partner iTeos Therapeutics announced on the same dayTop-line Results from the Latest Interim Analysis of GALAXIES Lung-201.This is a GSK-sponsored Phase II platform study aimed at evaluating the dual therapy of Belrestotug + Dostarlimab in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer. (NSCLC) The efficacy.

Data shows,The primary endpoint of the trial is the objective response rate. (ORR) Achieved clinically meaningful improvement, but inIn terms of secondary endpoints, progression-free survival,Belrestotug + Dostarlimab Combination Therapy vs. Dostarlimab Monotherapy: This Analysis Did Not Meet the Prespecified Criteria。

Moreover, the interim analysis of the GALAXIES H&N-202 Phase II trial showed that for PD-L1 positive head and neck squamous cell carcinoma patients, the combination therapy with Belrestotug demonstrated a comparison with Dostarlimab monotherapy.ORR Trend Below Meaningful Threshold。

Belrestotug is a human immunoglobulin G1 with Fc activity (IgG1) Monoclonal Antibody Targeting T Cell Immunoglobulin and Immune Receptor Tyrosine Inhibitory Motif Domain (TIGIT)。

June 2021,iTeos Therapeutics and GSK AnnounceCo-development and Commercialization Belrestotug。According to the terms of the cooperation agreement,iTeos TherapeuticsWill receive$625 millionThe advance payment, andUp to $1.45 billionDevelopment and commercial milestone payments.

Based on the results of two studies, this collaboration and all research cohorts involving Belrestotug will be terminated, including those currently ongoing.GALAXIES Lung-301 Phase III Trial New Enrollment.

On the TIGIT track, GSK is not the first to stumble. Prior to this,Roche, MSD, BeiGene, BMSBoth have successively terminated the TIGIT antibody research project.

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