Regulatory Focus - Friends of Cancer Research project tracks early cancer therapy response
The Friends of Cancer Research (FCR) has launched the next stage of a project that studies whether circulating tumor DNA changes can be used to track early response to cancer therapies.
The launch of Step 2 of the Circulating Tumor DNA for Monitoring Treatment Response (ctMoniTR) Project will involve data collection from over 3,000 cancer patients participating in more than 25 studies, said FCR in announcing the launch. Sixteen additional cancer treatments involving several different types of cancer are being studied, and preliminary results from Step 2 are expected by the end of 2022.
Step 1 of the project found that, for individuals with advanced lung cancer who received anti-programmed cell death protein-1 or anti-programmed death-ligand 1 (PD-1/PD-L1) therapy, ctDNA changes soon after treatment “were a strong indicator of long-term outcomes across multiple clinical trials,” according to a press release announcing the Step 2 launch. A publication detailing these results is forthcoming.
In Step 2 of ctMoniTR, researchers will look for more evidence to determine whether ctDNA changes can identify which patients are responding to therapy at an earlier timepoint than that determination can currently be made. Several drug classes and tumor types are being investigated, noted FCR. (RELATED: Multi-stakeholder team addresses tumor mutational burden harmonization, Regulatory Focus 16 July 2020)
“This is an opportunity to validate a new tool which would allow patients and physicians to know sooner and more accurately if treatments are working” said Jeff Allen, president & CEO of FCR. “Through this unique collaboration, the results will be faster and more robust than if everyone continues to investigate it independently.”
The project involves collaboration among 25 organizations, including major members of the pharmaceutical, life sciences and medical testing industries, the US Food and Drug Administration, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, and others.