2023 World Conference on Lung Cancer (Posters)-P2.06. Study Design to Assess Anti-TIGIT Mab Combination with Dostarlimab vs Pembrolizumab or Dostarlimab Monotherapy in NSCLC

P2.06. Study Design to Assess Anti-TIGIT Mab Combination with Dostarlimab vs Pembrolizumab or Dostarlimab Monotherapy in NSCLC - PDF(Slides)

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This document is a summary of a study design to assess the combination of an anti-TIGIT monoclonal antibody (mAb) with dostarlimab compared to either pembrolizumab or dostarlimab alone in patients with non-small cell lung cancer (NSCLC). The study aims to evaluate the antitumor activity and safety of the novel immunotherapy combinations and assess the dose-response relationship of the combinations. The CD226 axis, which includes the immunostimulatory receptor CD226 and the immunoinhibitory checkpoint receptor TIGIT, has emerged as a critical regulator of anticancer responses. In NSCLC, TIGIT expression is upregulated in activated T cells, and its inhibition may potentiate the therapeutic activity of PD-1 blockade. Previous Phase 2 trials have shown improved progression-free survival and objective response rate with TIGIT inhibition in patients with high PD-L1 expression. The study hypothesizes that the combination of dostarlimab, a PD-1 inhibitor, and belrestotug, a TIGIT inhibitor, may benefit patients with NSCLC. The study design is an open-label, randomized, adaptive Phase 2 platform study that will evaluate the efficacy, safety, and pharmacokinetics of different doses of belrestotug combined with dostarlimab. The primary endpoint is objective response rate, and secondary endpoints include progression-free survival, overall survival, and duration of response. Patients will be screened based on specific inclusion and exclusion criteria. The study is ongoing and is funded by GSK, with the support of iTeos Therapeutics as a collaborator. The study will involve multiple substudies, and an interim analysis will be conducted periodically to assess exposure response, dose response, and comparisons between study arms. This study design aims to provide valuable insights into the potential benefits of the novel immunotherapy combination in patients with NSCLC.

Asset Subtitle

Byoung Chul Cho

Meta Tag

Speaker Byoung Chul Cho

Topic Metastatic NSCLC: Immunotherapy - Prospective

Keywords

anti-TIGIT monoclonal antibody

dostarlimab

pembrolizumab

non-small cell lung cancer

NSCLC

immunotherapy combinations

CD226 axis

TIGIT inhibition

Phase 2 trial

belrestotug