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iTeos, GSK initiate GALAXIES Lung-301 Phase 3 Study of Belrestotug and Dostarlimab

20 Jun 2024
Admin
News Article

iTeos, GSK initiate GALAXIES Lung-301 Phase 3 Study of Belrestotug and Dostarlimab

iTeos, GSK initiate GALAXIES Lung-301 phase 3 study of belrestotug and dostarlimab in previously untreated, unresectable locally advanced/metastatic PD-L1 selected NSCLC

Overview

iTeos Therapeutics, Inc. (iTeos), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, and its development partner GSK, have initiated the first, global phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC).

Words from CEO: iTeos

“With the initiation of the first phase 3 study for belrestotug, we are entering a monumental stage in our journey to develop a world-leading oncology company. Nearly 70% of patients with first-line PD-L1 high non-small cell lung cancer rely upon a chemotherapy-free regimen. We believe belrestotug + dostarlimab are poised to potentially advance the therapeutic regimen in this setting and establish new benchmarks,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos.
“Based on our high-quality doublet exceeding its pre-defined efficacy criteria for clinically relevant activity in an interim assessment from the phase 2 GALAXIES Lung-201 study, we believe initiating the phase 3 program with this patient population will serve as the foundation to our broader strategy and marks our first step in building a franchise.”

GALAXIES Lung-301 trial

The randomized, double-blind, placebo-controlled, multicenter trial will enroll approximately 1,000 patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC in North America, South America, Europe and Asia.
The primary endpoints of the trial are progression free survival and overall survival.
In the GALAXIES Lung-301 trial, patients will be randomized 1:1 to either an intravenous infusion of the belrestotug + dostarlimab doublet or placebo + pembrolizumab.

Assessment of Phase 2 GALAXIES Lung-201

In May 2024, iTeos announced an interim assessment of the phase 2 GALAXIES Lung-201 study of the belrestotug + dostarlimab doublet in previously untreated, locally advanced, or metastatic PD-L1 selected NSCLC exceeded pre-defined efficacy criteria for clinically relevant activity and showed an acceptable safety profile in line with the TIGIT:PD-1 class.
Clinically meaningful tumour reduction was observed at every belrestotug + dostarlimab dose vs dostarlimab monotherapy.

Belrestotug

Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of innate immune responses against cancer.
As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and Fc?R, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC).
The therapeutic candidate is progressing in multiple indications in collaboration with GSK.

iTeos Therapeutics

iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients.