NEW YORK – Liquid biopsy firm Inivata said today that it is launching a prospective clinical study with France's Centre Léon Bérard cancer center to test whether its InVisionFirst-Lung test can get patients on appropriate treatment more quickly than tissue-based genetic testing.
The randomized Phase III interventional trial is called LIquid Biopsy for the Early detection of LUng cancer LEsion (LIBELULE). Investigators plan to enroll at least 286 patients across 17 clinical sites in France.
The primary endpoint — a reduction in time to treatment of more than 20 percent overall, or up to 50 percent for specific molecular subgroups — was chosen to answer the question of whether liquid biopsy assays like Inivata's can, or should, be used in routine clinical practice. However, investigators will also be measuring clinical outcomes, including progression-free survival.
"We are committed to continuing to build a highly robust body of evidence around the use of our liquid biopsy tests … and are proud to be working with high-quality teams around the world to develop a deeper understanding of the impact InVisionFirst-Lung can have on treatment," Inivata CEO Clive Morris said in a statement.
Various other liquid biopsy companies have also hit on the question of timely treatment decisions as a way to promote and advance their assays, with some, like Guardant Health, promoting a "blood first paradigm," in which liquid biopsy tests are ordered first and tissue sequencing becomes more of a backup or reflex for those with negative blood-based results.
Inivata's new study with Centre Léon Bérard will be the first of its kind to prospectively enroll and randomly stratify patients for therapeutic intervention based solely on a liquid biopsy result versus a tissue test.