iTeos Therapeutics announces first patient dosed in GALAXIES Lung-301 study

iTeos Therapeutics (ITO)S announced the dosing of the first patient in GALAXIES Lung-301, a global, randomized, double-blind Phase 3 registrational clinical trial of belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC. This event has triggered $35 million in development milestone payments from GSK (GSK), its partner for belrestotug. “Dosing the first patient in the GALAXIES Lung-301 study marks a significant milestone for belrestotug + dostarlimab. iTeos was founded with the goal of advancing therapeutic options for patients by leveraging best-in-class science. The decision to launch our first TIGIT:PD-1 doublet Phase 3 trial underscores our disciplined, data-driven investment approach and was informed by several promising preliminary clinical surrogates such as safety, ORR, and depth of response from the latest interim analysis in May 2024,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “We are excited about the ongoing Phase 2 GALAXIES Lung-201 trial and look forward to presenting data from the most recent interim analysis of this study at a medical meeting in 2024.”