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.
