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Investing.com -- Shares of iTeos Therapeutics, Inc. (NASDAQ:ITOS) climbed 11% today, even as the company announced the termination of its belrestotug development program. The decision came after the GALAXIES Lung-201 study, which evaluated belrestotug in combination with dostarlimab for the treatment of PD-L1 high non-small cell lung cancer (NSCLC), failed to meet the criteria for clinically meaningful improvements in progression-free survival.
Despite the unfavorable trial results, iTeos Therapeutics has initiated a strategic review to maximize shareholder value. The company’s CEO, Michel Detheux, Ph.D., expressed disappointment over the GALAXIES Lung-201 outcomes but emphasized the company’s commitment to evaluating strategic alternatives. iTeos has engaged TD Cowen to advise on the process, aiming to preserve and enhance shareholder value in light of the current market conditions.
The trial’s interim analysis showed a clinically meaningful improvement in the primary endpoint of objective response rate (ORR), but did not achieve the secondary endpoint of progression-free survival with the belrestotug and dostarlimab combination compared to dostarlimab monotherapy. Similarly, an interim analysis of the GALAXIES H&N-202 Phase 2 trial presented a trend below the meaningful threshold for ORR in the belrestotug combination cohorts versus dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma.
As a result of these findings, iTeos and its development partner GSK have agreed to discontinue the belrestotug program and end their collaboration. All belrestotug-containing cohorts will be terminated, and new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial will cease. GSK is in the process of informing investigators, review boards, and health authorities about the next steps for the management of currently enrolled patients.
Dr. Detheux highlighted the importance of sharing the data from the GALAXIES studies with the scientific community to advance the understanding of immuno-oncology and TIGIT. He also praised the team at iTeos for their commitment to science and improving the lives of cancer patients. With a robust balance sheet and a disciplined approach, iTeos is poised to explore opportunities that will unlock the value of its assets and benefit its shareholders.
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