KEY TAKEAWAYS
- The phase III LIBELULE trial aimed to hypothesize molecular testing using LB at the first patient visit could decrease TTI.
- The primary endpoint was the time to start the right treatment based on genetic and tumor test results.
- The study concluded that early LB could significantly reduce the TTI for patients with lung cancer.
Timely molecular testing is crucial for early treatment of advanced NSCLC. Researchers aimed to hypothesize molecular testing using liquid biopsy (LB) at the first patient visit could decrease treatment initiation (TTI).
The study created two arms; Arm A used the InVisionFirst-Lung assay for initial genomic testing, and treatment was based on the results, while Arm B followed ESMO guidelines after histological sampling and genomic analysis. The study aimed to enroll 286 patients (pts) to detect a 21% reduction in TTI (α = 0.05, 1-β = 90%).
Around 319 patients with suspected stage IV lung cancer were enrolled, with a median age of 68. The most common cancer type was adenocarcinoma (56.7%), followed by squamous cell carcinoma 11%, SCLC 10%, other 5%, and 5.3% had no cancer.
In Arm A, 81% had ctDNA findings; category 1 and 2 alterations were found in 29.2% (EGFR mut: 21.7%) and 24%. In Arm B, it was 23.2% (EGFR mut: 20.3%) and 20%. Treatment was started in 74.5% (Arm A) and 65.8% (Arm B). Mean TTI was 29.0 days (Arm A) vs. 33.9 days (Arm B) overall and significantly shorter in Arm A for systemic treatment (29.1 vs 38.8 days). TTI was shorter in category one alterations (21 vs. 37.4 days) and time to genomic analysis (17.9 vs. 25.6 days) in Arm A and B, respectively. 7.4% (Arm A) vs. 13.3% (Arm B) started treatment without genomic analysis.
The study found early LB can speed up identifying patients with actionable genomic alterations and starting treatment.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03721120
Aurélie Swalduz, Hubert Curcio, Bana Ambasager, Gabriel Le Moel, Didier Debieuvre, Jean Marc Dot, Michaël Duruisseaux, Pierre Fournel, Luc Odier, Sylvie Demolombe, Acya Bizieux-Thamany, Annie Peytier, Roland Schott, Stephane Hominal, Mathilde Donnat, Sandra Ortiz Cuaran, Camille Schiffler, Nitzan Rosenfeld, Pierre Saintigny, and Maurice Perol. DOI: 10.1200/JCO.2023.41.16_suppl.9019 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 9019-9019.
