iTeos Therapeutics, Inc. (ITOS) has outlined its strategic priorities for 2025, emphasizing the advancement of its immuno-oncology pipeline. The company anticipates multiple clinical data readouts throughout the year, particularly focusing on its TIGIT inhibitor, belrestotug, in combination with dostarlimab for first-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC).
Belrestotug Clinical Trials
iTeos is collaborating with GSK on the development of belrestotug (EOS-448/GSK4428859A), an IgG1 anti-TIGIT monoclonal antibody. The GALAXIES Lung-301 trial, a randomized, double-blind Phase 3 registrational study, is ongoing, assessing belrestotug plus dostarlimab versus placebo plus pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC. The FDA and NMPA have cleared the belrestotug 400mg + dostarlimab dose for Phase 3, enabling clinical site activation in the U.S. and China.
Interim data from the GALAXIES Lung-201 Phase 2 platform study, evaluating belrestotug plus dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line advanced/metastatic PD-L1 high NSCLC, are expected in the second quarter of 2025. The data will include safety, ORR, and ctDNA data from over 240 patients, with pembrolizumab monotherapy ORR for 30 patients and PFS data from initial 124 patients treated. These data are slated for presentation at a scientific congress in the second half of 2025.
For HNSCC, interim data from the GALAXIES H&N-202 Phase 2 platform study, assessing belrestotug plus dostarlimab doublet and triplet with nelistotug in first-line patients with PD-L1 positive recurrent/metastatic HNSCC, are anticipated in 2025, including safety and ORR data from over 150 patients. Topline data from the TIG-006 study in cohorts 2C & 2D, evaluating belrestotug plus dostarlimab doublet in first-line PD-L1 positive advanced/metastatic HNSCC, are also expected in 2025, featuring safety, ORR, and PFS data from a total of 42 patients.
Novel Pipeline Programs
iTeos is also advancing EOS-984, a potential first-in-class small molecule inhibiting ENT1, a dominant transporter of adenosine involved in T cell metabolism. Topline data from the APT-008 trial, assessing EOS-984 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, are anticipated in the second half of 2025.
Furthermore, an Investigational New Drug (IND) application for EOS-215, a potential best-in-class anti-TREM2 monoclonal antibody, is anticipated in the first quarter of 2025. EOS-215 targets tumor-associated macrophages to reprogram the tumor microenvironment.
Financial Position
As of September 30, 2024, iTeos reported a cash and investment balance of $683.9 million, which includes a $35.0 million milestone payment received from GSK related to the dosing of the first patient in the GALAXIES Lung-301 clinical trial. The company expects its cash balance to provide runway through 2027, supporting the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.
