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The global landscape of TIGIT-targeted cancer clinical trials: Trends, geographic shift, and policy implications
Ruihang Luo1, Maosen Liu1, Yichen Liu1
1Department of Thoracic Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi 330006, China; The First Clinical Medical College of Nanchang University, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi 330006, China.
Abstract:
TIGIT has emerged as a notable immune checkpoint in tumor immunotherapy following PD-1/L1, though recent Phase III setbacks have tempered early optimism. This study systematically analyzed 241 unique clinical trial protocols of TIGIT-targeted cancer therapies as of December 31, 2025, based on the Informa Trialtrove database. Counting each trial protocol once regardless of geographic footprint, China led globally with participation in 203 trials when counting by country involvement, and non-small cell lung cancer was the most dominant indication. The trial termination or closure rate exceeded 30%, comparable to or higher than historical benchmarks for PD-1/PD-L1 agents at similar development stages. Monoclonal antibodies dominated the landscape (94.6%), with the research focus shifting from pure target competition toward Fc domain functional regulation and synergistic strategies such as bispecific antibodies. However, the high degree of mechanistic convergence, with over 80% of trials testing similar combination regimens, raises questions about global R&D resource allocation efficiency.This study provides a panoramic data reference for drug development and clinical decision-making in the TIGIT field.
Insights
Despite recent setbacks, TIGIT immune checkpoint inhibitors are advancing in cancer immunotherapy. Analysis of 241 trials reveals high global participation, particularly from China, but also a significant trial closure rate and concerns over R&D efficiency.
Area of Science:
- Immunology
- Oncology
- Clinical Trials
Background:
- TIGIT (T cell immunoglobulin and ITIM domain) is a key immune checkpoint target in cancer immunotherapy.
- Recent Phase III trial results for TIGIT inhibitors have faced challenges, impacting early optimism.
- Understanding the current landscape of TIGIT-targeted clinical trials is crucial for future drug development.
Purpose of the Study:
- To systematically analyze the global clinical trial landscape for TIGIT-targeted cancer therapies.
- To identify trends in trial design, indications, and development strategies.
- To assess the efficiency of global research and development resource allocation in the TIGIT field.
Main Methods:
- Systematic analysis of 241 unique clinical trial protocols for TIGIT-targeted cancer therapies as of December 31, 2025.
- Data sourced from the Informa Trialtrove database.
- Analysis included trial counts by country, dominant indications, termination rates, therapeutic modalities, and combination strategies.
Main Results:
- China led global participation with 203 trials; non-small cell lung cancer was the most frequent indication.
- The trial termination/closure rate exceeded 30%, comparable to or higher than PD-1/PD-L1 agents.
- Monoclonal antibodies were dominant (94.6%), with a shift towards Fc domain regulation and bispecific antibodies.
- Over 80% of trials employed similar combination regimens, indicating mechanistic convergence.
Conclusions:
- The TIGIT field shows significant clinical trial activity but faces challenges with high termination rates.
- Current research emphasizes Fc-domain modifications and synergistic combinations, moving beyond simple target competition.
- The high degree of mechanistic convergence warrants a re-evaluation of global R&D resource allocation efficiency for TIGIT therapies.
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