Circulating Tumor DNA (ctDNA) | Friends of Cancer Research

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Circulating Tumor DNA (ctDNA)

ctDNA for Monitoring Treatment Response (ctMoniTR) Project

Recent Updates: On November 12, 2019, Friends posted a press release announcing the launch of the ctMoniTR Project. 

The Problem: The use of circulating tumor DNA (ctDNA) to monitor treatment response is an important and timely area of investigation. It has been particularly challenging to investigate ctDNA's role as a monitoring tool for treatment response due to variability in the way ctDNA assessment has been designed into clinical trials, the various collection methods used, and the way ctDNA changes are reported by different ctDNA assays.

 

The Solution: Friends of Cancer Research (Friends) has created a pilot project involving several key stakeholders with the objective to harmonize the use of ctDNA to Monitor Treatment Response (ctMoniTR), to better answer the pressing question: Do changes in ctDNA levels accurately reflect the therapeutic effect of cancer therapies? 

 

The project has a multi-step approach that was launched in fall of 2019. The steps include:

 

  • Step 1: The study of ctDNA as a monitoring tool in previously collected trial data from a subset of trials (e.g. NSCLC treated with ICI)
  • Step 2: The study of ctDNA as a monitoring tool in prospectively collected trial data from various types of advanced cancer and therapies (e.g. ICIs, TKIs, chemotherapy)


Step 1 will assess the feasibility of investigating the directionality of change in ctDNA levels from baseline and investigate its association with patient response by looking at a smaller cohort of trials with a specific indication. Results from Step 1 will inform Step 2, which will investigate the ability of ctDNA to detect early therapeutic response in clinical trials for different indications and different treatments. The hypothesis under which this project operates is that broad changes in ctDNA levels can detect tumor response to cancer therapies, including immune checkpoint inhibitors, targeted therapies, and chemotherapy.

 

 

The Background

  • This project builds off of Friends' previous work in the field, including the Friends Annual Meeting 2018 whitepaper
  • Building on the whitepaper and feedback from the 2018 Annual Meeting, Friends developed a proposal for this project. In February of 2019, Friends hosted a full-day roundtable meeting to review the proposal, ultimately reaching consensus to execute the collaborative project.

 

Partners:

There are eight partners participating in Step 1 of the ctMoniTR Project, including: AstraZeneca, Bristol-Myers Squibb, Genentech, Johns Hopkins University, LexentBio, Merck, the NMD Group LLC, and the U.S. Food and Drug Administration.