All Times EDT
Keywords: patient-level data, ctDNA, collaboration
Multiple post hoc study reports have been published suggesting a role for Circulating Tumor DNA (ctDNA) in various aspects of drug development. To evaluate these signals more comprehensively, a two-step collaborative effort was launched by Friends of Cancer Research (Friends) focused on Patient-Level data from multiple studies. A consortium of drug developers, assay developers, regulators, and academics have worked to bring together data and appropriate statistical analyses to answer the question: Do changes in ctDNA reflect response to treatment? Step 1 of the project was based on a limited set of cohorts (n=7, 200 patients and 5 assay types). We showed consistent association between reductions in ctDNA and improved treatment outcomes. We also demonstrated statistical techniques could be developed to harmonize the data across trials and assays. Step 2 of the ctMoniTR project is underway with over 40 cohorts in 3 distinct clinical settings representing close to 5000 patients. In this talk, we’ll summarise the results of Step 1 and present the current status of Step 2. We’ll share our statistical approaches in the context of aggregated patient-level data modelling. We’ll present lessons learned from this collaborative approach as we explore how our findings inform future drug development and ctDNA use.