Friends of Cancer Suggest ctDNA as Early Endpoint in Drug Research

The biomarker known as circulating tumor DNA (ctDNA) is well-suited to become an early endpoint in oncology, as it has the potential to improve confidence in the efficacy of novel therapies, thus bringing better treatments to patients faster.

That’s according to a report from a multistakeholder oncology-focused working group convened by the nonprofit cancer research think tank and advocacy organization Friends of Cancer Research. The group included the FDA, drug sponsors, ctDNA assay developers and academic clinicians.

The report from the meeting focused on ctDNA as a valuable early endpoint to predict long-term survival outcomes to support regulatory approval, noting the need for collaboration across sponsors if the biomarker is going to come to full fruition.

Friends of Cancer Research previously established a collaborative research initiative to harmonize the use of ctDNA to monitor treatment response to determine if changes in ctDNA levels accurately reflect the therapeutic effect of immunotherapies in advanced lung cancer.