BFAST Trial Validates Liquid Biopsy-Guided Entrectinib for ROS1-Positive Lung Cancer
The BFAST trial Cohort D demonstrated an 81.5% confirmed response rate with entrectinib in ROS1-positive advanced NSCLC identified exclusively by liquid biopsy, consistent with tissue-based results from prior studies. These findings validate the clinical utility of blood-based genomic testing for identifying actionable ROS1 fusions and support liquid biopsy as a practical alternative when tissue is unavailable.
The original study
Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial.
- Authors
- Peters S, Gadgeel SM, Mok T, Nadal E, Kilickap S, Swalduz A, et al.
- Journal
- Nature medicine
- Type
- Journal Article, Clinical Trial, Phase II, Clinical Trial, Phase III, Multicenter Study
- PMID
- 38898120
Original abstract
Although comprehensive biomarker testing is recommended for all patients with advanced/metastatic non-small cell lung cancer (NSCLC) before initiation of first-line treatment, tissue availability can limit testing. Genomic testing in liquid biopsies can be utilized to overcome the inherent limitations of tissue sampling and identify the most appropriate biomarker-informed treatment option for patients. The Blood First Assay Screening Trial is a global, open-label, multicohort trial that evaluates the efficacy and safety of multiple therapies in patients with advanced/metastatic NSCLC and targetable alterations identified by liquid biopsy. We present data from Cohort D (ROS1-positive). Patients ≥18 years of age with stage IIIB/IV, ROS1-positive NSCLC detected by liquid biopsies received entrectinib 600 mg daily. At data cutoff (November 2021), 55 patients were enrolled and 54 had measurable disease. Cohort D met its primary endpoint: the confirmed objective response rate (ORR) by investigator was 81.5%, which was consistent with the ORR from the integrated analysis of entrectinib (investigator-assessed ORR, 73.4%; data cutoff May 2019, ≥12 months of follow-up). The safety profile of entrectinib was consistent with previous reports. These results demonstrate consistency with those from the integrated analysis of entrectinib in patients with ROS1-positive NSCLC identified by tissue-based testing, and support the clinical value of liquid biopsies to inform clinical decision-making. The integration of liquid biopsies into clinical practice provides patients with a less invasive diagnostic method than tissue-based testing and has faster turnaround times that may expedite the reaching of clinical decisions in the advanced/metastatic NSCLC setting. ClinicalTrials.gov registration: NCT03178552 .