Cecilia Brown

Lung Cancers Today

The development program for the anti-TIGIT monoclonal antibody belrestotug is ending, according to an announcement today from GSK plc and iTeos Therapeutics, Inc. This news came alongside the report of topline results from the updated interim analysis of GALAXIES Lung-201.
The phase 2 platform study has been assessing the combination of belrestotug plus dostarlimab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC). The analysis “did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progressionfree survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy,” officials said in the announcement.
They noted that the GALAXIES Lung-201 data “continued to demonstrate clinically meaningful improvements in the trial’s primary endpoint of objective response rate (ORR),” but explained that an interim analysis of the phase 2 GALAXIES H&amp;N-202 trial “showed 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.”
Officials explained how the results impacted the choice to halt the program and what the next steps will be.
“Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration,” officials said in the announcement. “All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial is ending. GSK is communicating with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled patients.”
Michel Detheux, PhD, president and chief executive officer of iTeos, weighed in on the results and decision in a statement.
“We are truly disappointed by the results from GALAXIES Lung-201,” Dr. Detheux said. “Following the analysis of the TIGIT data generated to-date with GSK, we have made the mutual decision to discontinue development of all ongoing TIGIT studies. We are grateful to all patients, caregivers, and investigators involved in the GALAXIES studies and believe it is important to share these data with the scientific community at an upcoming medical meeting in order to advance our collective understanding of immuno-oncology and TIGIT.”
In the announcement from iTeos, officials explained that the company is “taking immediate steps to preserve capital and has initiated a targeted process to identify opportunities that preserve and maximize shareholder value.”
Source:
iTeos Therapeutics, Inc. <a href="https://www.globenewswire.com/news-release/2025/05/13/3080020/0/en/iTeos-Reports-Topline-Interim-Results-from-GALAXIES-Lung-201-Study-of-Belrestotug-Dostarlimab-in-First-Line-PD-L1-High-Non-Small-Cell-Lung-Cancer-Patients.html" target="_blank" rel="noopener">https://www.globenewswire.com/news-release/2025/05/13/3080020/0/en/iTeos-Reports-Topline-Interim-Results-from-GALAXIES-Lung-201-Study-of-Belrestotug-Dostarlimab-in-First-Line-PD-L1-High-Non-Small-Cell-Lung-Cancer-Patients.html</a>. Accessed May 13, 2025.

The development program for the anti-TIGIT monoclonal antibody belrestotug is ending, according to an announcement today from GSK plc and iTeos Therapeutics, Inc. This news came alongside the report of topline results from the updated interim analysis of GALAXIES Lung-201.The phase 2 platform study has been assessing the combination of belrestotug plus dostarlimab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC). The analysis “did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progressionfree survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy,” officials said in the announcement.They noted that the GALAXIES Lung-201 data “continued to demonstrate clinically meaningful improvements in the trial’s primary endpoint of objective response rate (ORR),” but explained that an interim analysis of the phase 2 GALAXIES H&amp;N-202 trial “showed 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.”Officials explained how the results impacted the choice to halt the program and what the next steps will be.“Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration,” officials said in the announcement. “All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial is ending. GSK is communicating with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled patients.”Michel Detheux, PhD, president and chief executive officer of iTeos, weighed in on the results and decision in a statement.“We are truly disappointed by the results from GALAXIES Lung-201,” Dr. Detheux said. “Following the analysis of the TIGIT data generated to-date with GSK, we have made the mutual decision to discontinue development of all ongoing TIGIT studies. We are grateful to all patients, caregivers, and investigators involved in the GALAXIES studies and believe it is important to share these data with the scientific community at an upcoming medical meeting in order to advance our collective understanding of immuno-oncology and TIGIT.”In the announcement from iTeos, officials explained that the company is “taking immediate steps to preserve capital and has initiated a targeted process to identify opportunities that preserve and maximize shareholder value.”Source:iTeos Therapeutics, Inc. <a href="https://www.globenewswire.com/news-release/2025/05/13/3080020/0/en/iTeos-Reports-Topline-Interim-Results-from-GALAXIES-Lung-201-Study-of-Belrestotug-Dostarlimab-in-First-Line-PD-L1-High-Non-Small-Cell-Lung-Cancer-Patients.html" target="_blank" rel="noopener">https://www.globenewswire.com/news-release/2025/05/13/3080020/0/en/iTeos-Reports-Topline-Interim-Results-from-GALAXIES-Lung-201-Study-of-Belrestotug-Dostarlimab-in-First-Line-PD-L1-High-Non-Small-Cell-Lung-Cancer-Patients.html</a>. Accessed May 13, 2025.

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Officials Announce Topline Results From GALAXIES Lung-201 and Halt Development of Belrestotug

The development program for the anti-TIGIT monoclonal antibody belrestotug is ending, according to an announcement from GSK plc and iTeos Therapeutics, Inc.