iTeos Therapeutics Reports Promising ORR in Lung Cancer Study

Iteos Therapeutics, Inc. has released follow-up interim data from the galaxies lung-201 study, which is assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced, or metastatic PD-L1 high non-small cell lung cancer (NSCLC). The study showed a clinically meaningful objective response rate (ORR) of 63.3-76.7% with belrestotug + dostarlimab combinations, with a confirmed ORR (CORR) at ~60% for every dose. This represents a >30% CORR difference between belrestotug + dostarlimab vs dostarlimab monotherapy.

As of the June 7, 2024 data cutoff, the interim data were based on 124 patients eligible for safety and efficacy evaluation. The ORR improvement was observed consistently across each belrestotug + dostarlimab cohort, with CORR roughly at 60.0% for each dose compared to 28.1% for dostarlimab alone. Belrestotug + dostarlimab also led to an increase in immune-related adverse events compared to dostarlimab monotherapy, which were generally manageable.

The phase 2 galaxies lung-201 study is a randomized, open-label, global platform study evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with PD-L1 high NSCLC. Arms and interventions in this study include pembrolizumab (anti-PD-1) monotherapy, dostarlimab (anti-PD-1) monotherapy, belrestotug (anti-TIGIT) + dostarlimab doublet combination, and belrestotug + dostarlimab + nelistotug (anti-CD96) triplet combination.

The follow-up interim data will be discussed during a conference call and webcast presentation on Monday, September 16th, 2024 at 8:00 am ET.

Iteos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. The company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. As a result of these announcements, the company's shares have moved -1.2% on the market, and are now trading at a price of $16.7. Check out the company's full 8-K submission here.

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