iTeos Therapeutics, Inc. (NASDAQ:ITOS) reported topline results from an updated interim analysis of the GALAXIES Lung-201 Phase 2 study on Tuesday.
The trial sponsored by GSK Plc (NYSE:GSK) assessed the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced, or metastatic PD-L1 high non-small cell lung cancer (NSCLC).
The GALAXIES Lung-201 data demonstrated clinically meaningful improvements in the trial’s objective response rate (ORR) endpoint.
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However, the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression-free survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy.
An interim analysis of the GALAXIES H&N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma.
Based on these results, iTeos and GSK have decided to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial will end.
iTeos Therapeutics said it is taking immediate steps to preserve capital and has initiated a targeted process to identify opportunities that preserve and maximize shareholder value. iTeos has engaged TD Cowen to advise on this process.
“Given current market conditions and our appreciation of the responsibility to our valued shareholders, we believe the best path forward is to promptly evaluate a full range of strategic alternatives to unlock the value of our assets. With a strong balance sheet and a commitment to disciplined execution, we are well-positioned to pursue opportunities that maximize shareholder value,” said Michel Detheux, president and CEO of iTeos.
In April, iTeos said its cash and investments position was $624.3 million as of March 31, 2025, which is expected to provide a cash runway into 2027.
Price Action: ITOS stock is up 17.3% at $8.12 at the last check on Tuesday.
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