iTeos Therapeutics has reported promising interim results from its Phase 2 GALAXIES Lung-201 study evaluating the combination of belrestotug (bel) with dostarlimab (dos) in frontline PD-L1-high non-small cell lung cancer (NSCLC) patients. The combination therapy has demonstrated a significant improvement in objective response rate (ORR) compared to dostarlimab monotherapy, marking a potential advancement in NSCLC treatment.
Clinical Trial Progress and Expected Milestones
The company is advancing toward a critical milestone with the release of pivotal data from the Phase 2 GALAXIES Lung-201 study anticipated in 2025. A key focus will be on the median progression-free survival (mPFS) data, which will provide crucial insights into the durability of the treatment response. This data is particularly significant as it could validate the therapeutic potential of the belrestotug-dostarlimab combination.
Parallel to the NSCLC studies, iTeos is conducting Phase 2 trials investigating the combination therapy in head and neck squamous cell carcinoma (HNSCC). Results from these studies are also expected in 2025, potentially expanding the treatment's application across multiple cancer types.
Strategic Implications and Market Potential
The positive interim results have significant implications for the ongoing Phase 3 GALAXIES Lung-301 study. Success in the Phase 2 trial could strengthen the competitive position of the belrestotug-dostarlimab combination in the expanding immunotherapy market for NSCLC treatment.
H.C. Wainwright analyst Swayampakula Ramakanth, maintaining a Buy rating with a price target of $21.00, emphasized the promising potential of this combination therapy. "The interim results suggest strong therapeutic potential for the belrestotug-dostarlimab combination in frontline NSCLC treatment," noted Ramakanth.
Development Pipeline and Company Focus
iTeos Therapeutics continues to advance its immuno-oncology pipeline, with belrestotug representing a key asset in their portfolio. The drug, when combined with dostarlimab, demonstrates the company's commitment to developing innovative approaches in cancer immunotherapy.
The company's strategic focus on both NSCLC and HNSCC indicates a comprehensive approach to addressing significant unmet needs in oncology. These developments align with iTeos's mission to expand treatment options for cancer patients through novel immunotherapy combinations.
