iTeos and GSK halt lung cancer drug development

WATERTOWN, Mass. and GOSSELIES, Belgium - iTeos Therapeutics, Inc. (NASDAQ: ITOS), a biopharmaceutical company with a market capitalization of $265 million, and its partner GSK have decided to discontinue their belrestotug development program for lung cancer treatment following underwhelming trial results. According to InvestingPro data, the company’s stock has declined nearly 60% over the past year, though it maintains a strong balance sheet with more cash than debt. The announcement came after the Phase 2 GALAXIES Lung-201 study did not show clinically meaningful improvements in progression-free survival for patients with PD-L1 high non-small cell lung cancer (NSCLC).

The study, which evaluated the combination of belrestotug and dostarlimab, did demonstrate improvements in objective response rate (ORR), but failed to meet the criteria for progression-free survival compared to dostarlimab monotherapy. Additionally, an interim analysis of the GALAXIES H&N-202 Phase 2 trial in head and neck squamous cell carcinoma also showed ORR trends below meaningful levels.

As a result of these findings, all belrestotug-containing cohorts in ongoing studies, including the GALAXIES Lung-301 Phase 3 trial, are being terminated, and no new patient enrollment will occur. GSK is in the process of informing investigators and health authorities about the next steps for managing currently enrolled patients.

iTeos President and CEO Michel Detheux expressed disappointment with the trial outcomes but emphasized the company’s commitment to sharing the data with the scientific community to further the understanding of immuno-oncology and TIGIT, a receptor involved in immune response suppression against cancer.

In light of the current market conditions, iTeos is undertaking a strategic review to maximize shareholder value, with financial advisory firm TD Cowen assisting in this process. Despite the setback, iTeos maintains a strong balance sheet with a remarkable current ratio of 14.13 and is exploring opportunities to leverage its assets. InvestingPro analysis suggests the stock may be undervalued at current levels, with additional insights available through their comprehensive financial health assessment tools.

Belrestotug, an anti-TIGIT monoclonal antibody, was designed to enhance antitumor responses through immune modulation. However, the decision to cease its development underscores the challenges and uncertainties inherent in drug development, particularly in the competitive field of immuno-oncology. While iTeos receives a FAIR overall financial health score from InvestingPro, analysts do not anticipate profitability this year, highlighting the importance of monitoring the company’s strategic direction.

The information in this article is based on a press release statement from iTeos Therapeutics.

In other recent news, iTeos Therapeutics reported a narrower-than-expected loss for the first quarter of 2025. The company posted a net loss of $34.6 million, or $0.80 per share, which was better than analyst estimates of a $0.93 per share loss. Despite not reporting any revenue for the quarter, iTeos remains focused on advancing its pipeline of immuno-oncology therapeutics. Research and development expenses decreased to $29.0 million from $34.5 million year-over-year, primarily due to the phasing of belrestotug studies and discontinuation of the inupadenant program. The company ended the quarter with a strong cash position of $624.3 million, which it expects will support operations through 2027. iTeos anticipates several key clinical readouts in the coming quarters, including interim data from GALAXIES Lung-201. The company is planning potential Phase 3 trials for its lead candidate belrestotug in combination with dostarlimab. Michel Detheux, president and CEO, mentioned that while preliminary findings are encouraging, further investment will be based on clear evidence of benefit in clinical studies.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.