New Project Aims to Harmonize ctDNA for Monitoring Treatment Response
Washington, DC – November 12, 2019 – Today, Friends of Cancer Research (Friends) announced the launch of its latest project, ctMoniTR. This pilot project will aim to harmonize the use of circulating tumor DNA (ctDNA) to monitor treatment response in cancer patients and test the feasibility of data comparison from different clinical studies.
“Through this unique collaboration, we seek to answer the question: do changes in circulating tumor DNA levels accurately reflect the therapeutic effect of cancer treatments,” said Friends’ President & CEO, Jeff Allen. “Working with multiple partners will develop the necessary evidence about the use of ctDNA in a way that is faster and more robust than if everyone continues to investigate it independently.”
Friends of Cancer Research is pleased to partner with various organizations participating in Step 1 of the ctMoniTR Project. These include AstraZeneca, Bristol-Myers Squibb, Genentech, Johns Hopkins University, LexentBio, Merck, the NMD Group LLC, and the U.S. Food and Drug Administration.
Circulating tumor DNA is genetic material that is shed from cancer cells and can be measured in the blood. The team hypothesizes that broad changes in ctDNA levels can detect whether a tumor responds to cancer therapies, including chemotherapy, radiation therapy, targeted therapies, and novel immunotherapy approaches, such as immune checkpoint inhibitors.
The use of ctDNA to monitor treatment response is an evolving field with both technical and clinical challenges. This is due in part to the variability in how it has been utilized in clinical trials and the variation in collection methods and analysis.
At the Friends Annual Meeting in 2018, liquid biopsy experts discussed the role of ctDNA for monitoring a patient’s tumor response over time and developed a whitepaper that laid the rationale for the use of ctDNA as a feasible and less-invasive method to assess tumor response to treatment in patients with cancer. The whitepaper also proposed a framework for a uniform collection method that would enable the aggregation and comparison of data and findings across different studies within and across different disease sites and stages.
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 being launched today.
The project will be broken out into two steps. Step 1 will use previously collected trial data from a subset of lung cancer trials to study the feasibility of ctDNA as a monitoring tool. Step 1 results will inform Step 2, which will prospectively investigate the ability of ctDNA to detect early tumor response to treatment in clinical trials for different cancer types and treatments.
For more information on the project, please visit: www.focr.org/ctdna.
About Friends of Cancer Research
Friends of Cancer Research (Friends) drives collaboration among partners from every healthcare sector to power advances in science, policy and regulation that speed lifesaving treatments to patients. For more information, please visit www.focr.org.