Study shows potential of ctDNA as biomarker for immunotherapy response in GU cancers

here was a higher concordance of somatic alterations between tissue and ctDNA testing in patients with metastases vs those without.

“By understanding the mirSNP genetic markers that predispose patients to adverse side effects from cancer therapy we can tailor these therapies to minimize harm and maximize efficacy," says Joanne B. Weidhaas, MD, PhD, MS.

This announcement follows an earlier FDA decision to grant approval to the company’s tissue-based comprehensive genomic profiling test FoundationOne CDx for the same therapy and indication in August 2023.

The positive CHMP opinion is supported by findings from cohort 1 of the phase 3 THOR trial.

"This information, and future expansions of this work could help refine the ways in which key clinical decisions are made..." says Michael S. Leapman, MD, MHS.

“Even when we adjusted for other clinical variables, like age or grade of tumor, this signature was still independently associated with recurrence after treatment for this form of kidney cancer," says Simpa S. Salami, MD, MPH.