GSK and iTeos Report 60% Objective Response Rate with TIGIT/PD-1 Combination Therapy in First-Line NSCLC

Sep 14, 2024 17:23 CST Updated 17:23

GSK

Pharmaceutical R&D Manufacturer

As the "new star of immunity," TIGIT inhibitors once became the new traffic code. The high-priced acquisitions by MNCs also broadened the imaginative space for this track, but the successive news of failures has made the prospect of TIGIT unclear.

Last month, Merck terminated the Phase III trial of its TIGIT candidate vibostolimab in combination with Keytruda for the treatment of extensive-stage SCLC. Prior to this, BMS exited its TIGIT collaboration project with Agenus and returned the jointly developed TIGIT/CD96 bispecific antibody. In July, Roche announced that its TIGIT monoclonal antibody tiragolumab failed to meet the primary endpoint in a Phase II/III clinical trial targeting NSCLC.

As investors generally held a pessimistic attitude towards such drugs, GSK's positive data on the combination therapy of TIGIT and PD-1 has cleared some clouds for research in this field.

At the ESMO conference these two days,GSK and iTeos Announce Interim Data from Phase II Trial of PD-1 Antibody Jemperli (dostarlimab) in Combination with iTeos' TIGIT Drug BelrestotugGALAXIES Lung-201 trial compares dostarlimab plus belrestotug versus dostarlimab alone in previously untreated patients with locally advanced or metastatic NSCLC exhibiting high PD-L1 expression, with the primary endpoint being the objective response rate at 24 months.（ORR）。

In 124 patients, compared with the 28.1% response rate of dostarlimab monotherapy, the ORR of all three dose groups of belrestotug combined with dostarlimab reached 60% in first-line NSCLC patients with high PD-L1 expression.

It should be noted that,These are the data for partial remission, and there is currently no disclosure of complete remission data.

Adding belrestotug to dostarlimab led to an increase in immune-related adverse events, but iTeos stated that these were manageable. The most common side effects were skin and subcutaneous tissue disorders.（50%）And Endocrine Diseases（26%）。

iTeos CEO Michel Detheux said in an interview before the conference, "We have set a new standard for the response rate in this patient population." An analysis conducted on first-line NSCLC patients with high PD-L1 expression treated with Keytruda monotherapy showed an ORR of 44.4% for the drug.

In June this year, GSK and iTeos initiated the Phase III GALAXIES Lung-301 trial to study dostarlimab in combination with belrestotug versus Keytruda plus placebo in the same patient population. The study will enroll approximately 1,000 patients and will use progression-free survival and overall survival as the primary endpoints.

In June 2021, GSK announced a collaboration with iTeos to develop and promote Belrestotug for an upfront payment of $625 million and potential total milestone payments of up to $1.45 billion. Belrestotug is a TIGIT antibody with multiple mechanisms of action that activates T cells and natural killer cells while eliminating immunosuppressive regulatory T cells.（Treg）And other methods to enhance anti-cancer immune responses.

Detheux also revealed that, in theory, the combination of belrestotug with other drugs might benefit lung cancer patients with lower PD-L1 levels, but further research is needed.

Reference Article:

1、GSK, iTeos rejuvenate struggling TIGIT space with positive Phase 2 Jemperli combo data in lung cancer；endpoints

2. Response Rate Doubled: GSK's TIGIT+PD-1 Combination Therapy Achieves Breakthrough in Non-Small Cell Lung Cancer; UmabsDB

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