GSK, partner iTeos end development programme for lung cancer drug belrestotug

The decision is based on new interim analyses from the phase 2 GALAXIES Lung-201 and GALAXIES H&N-202 studies, which did not meet the established efficacy criteria for continued development.

GALAXIES Lung-201 is the Phase 2 platform study sponsored by iTeos’ development partner GSK assessing 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 continued to demonstrate clinically meaningful improvements in the trial’s primary endpoint of objective response rate (ORR), 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. Additionally, 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.

As a result, the collaboration and all belrestotug-containing study cohorts are ending. 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. The Company 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.

“We are truly disappointed by the results from GALAXIES Lung-201,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “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.”

“Since founding this company over a decade ago, I could not be prouder of the team we have built, the quality of science produced, and our collective commitment to improving the lives of cancer patients in need. However, 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,” continued Dr. Detheux.