Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology

This publication explores a refined quantitative framework for using model-based tumor growth inhibition (TGI) metrics to support early Go/No-Go decisions in oncology drug development. The authors evaluate the operating characteristics of several TGI metrics and compare their ability to identify treatment effects with conventional endpoints, including objective response rate and progression-free survival. The analysis highlights the potential of model-based TGI metrics, particularly the tumor size ratio at Week 24 (TR24), to provide earlier and more informative evidence for determining whether a development program is ready to advance to a pivotal trial. The findings also underscore the importance of study design and modeling methodology when applying these approaches to development decisions.