GSK Exits TIGIT Program as iTeos Therapeutics Winds Down Operations Following Belrestotug Clinical Setback

Another Major TIGIT Drug Fails: GSK Retreats from TIGIT, Ending the Original Research Company.

Recently,iTeos Therapeutics Report, EvaluationBelrestotug (TIGIT Antibody) + Dostarlimab (PD-1 Antibody)) Phase 2 Clinical StudyIn GALAXIES Lung-201, the secondary endpoint was not met.Does not meet the established criteria for clinically meaningful improvement in progression-free survival.

Based on the overall data,iTeos &GSK has terminatedThe development plan for belrestotug. Meanwhile,iTeos has initiated a targeted review of strategic alternatives to maximize shareholder value.

In 2020, Roche advanced with the Phase 2 study of TIGIT+PD-1 combinationCITYSCAPE has sparked a global research craze for TIGIT.

GSK quickly followed up in 2021June, in$625 million upfront and additional$1.45 Billion in Development and Commercialization MilestonesFuPayment, andiTeos reached an agreement to jointlyDevelopment and Commercialization of TIGIT Monoclonal AntibodyEOS-448（belrestotug/GSK4428859A）。

Thereafter, GGSK purchased thisTIGIT Monoclonal Antibody and Its PD-1 Monoclonal AntibodyDostarlimab Joint Development Initiates Multiple Clinical Studies, including 1L treatmentHigh PD-L1 ExpressionNon-Small Cell Lung Cancer (Phase 2 Study of NSCLCGALAXIES Lung-201 andPhase 3 StudyGALAXIESLung-301, as well as targetingSquamous Cell Carcinoma of the Cervix (HNSCC)GALAXIES H&N-202 andTIG-006。

But after reviewing the latest data,GSK Still Decides to Give Upbelrestotug。

In fact, according to the data released so far,Belrestotug CombinationDostarlimab inThe response rate for NSCLC is relatively positive.

ESMO 2024At the annual meeting,GSK announcedGALAXIES Lung-201 Trial Data Shows: Threebelrestotug+In the dostarlimab dose cohortA clinically meaningful improvement in the primary endpoint of ORR was consistently observed, with an ORR of 63.3% in Cohort A, 65.6% in Cohort B, and 76.7% in Cohort C., andThe cORR of the dostarlimab monotherapy control group was 37.5%; the difference in cORR between the combination therapy group and the monotherapy control group was >30% (60.0% vs 28.2%).ButDostarlimab has not been approved asStandard Treatment for High PD-L1 Expression in Non-Small Cell Lung Cancer.

The latest data update also shows,GALAXIES Lung-201 continues to show clinically meaningful improvement in the primary endpoint ORR.

AndMainThe main issues appeared inProgression-Free Survival, this isA secondary endpoint of GALAXIES Lung-201.

Topline results from the latest interim analysis of GALAXIES Lung-201 show that, compared withCompared with dostarlimab monotherapy,belrestotug+Dostarlimab Combination in Progression-Free Survival Secondary EndpointUp`, not reached`Established criteria for clinically meaningful improvement.

In addition`, one`belrestotug+Dostarlimab Combination1L Treatment for PD-L1+ Phase 2 Trial of HNSCCThe interim analysis of GALAXIES H&N-202 shows that, compared withCompared with dostarlimab monotherapy,belrestotug+The ORR trend in the dostarlimab combination cohort was below the meaningful threshold.

Based on these results,GSK andiTeos Decides to TerminateThe development project of belrestotug has been terminated and the cooperation has ended. All containingThe cohorts of belretotug are all ending, with the ongoing Phase 3 study.GALAXIES Lung-301 will cease enrollment of any new patients. GSK is communicating with investigators, Institutional Review Boards, ethics committees, and health authorities regarding the appropriate management and next steps for currently enrolled patients.

In the past decade, TIGIT was once the hottest target in cancer immunotherapy and was regarded as the next "PD-1".

But in the past few years of development, TIGIT has been questioned and later confirmed.

As Roche, Bristol-Myers Squibb (BMS), Merck, Gilead and other giants have suffered setbacks one after another in TIGIT development. Now, GSK has also failed in TIGIT.

Basically, all the major pharmaceutical companies that have entered the TIGIT field have failed once.

Currently, onlyGilead andA collaboration with ArcusTIGIT blockers are in Phase 3 studies, with data expected to be released next year.

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