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Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial
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Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial
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Journal Article
Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial
2024
Overview
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
.
Results from this single-arm cohort of the BFAST trial showed that the clinical efficacy of entrectinib in patients with
ROS1
-positive NSCLC, selected using liquid biopsies, is consistent with that seen in previous reports where patients were selected using tissue-based testing methods.
Publisher
Springer Science and Business Media LLC,Nature Publishing Group US,Nature Publishing Group
Subject
/ Adult
/ Aged
/ Benzamides - therapeutic use
/ Biomarkers, Tumor - genetics
/ Biomarkers, Tumor - metabolism
/ Biomedical and Life Sciences
/ Biopsy
/ Carcinoma, Non-Small-Cell Lung - drug therapy
/ Carcinoma, Non-Small-Cell Lung - genetics
/ Carcinoma, Non-Small-Cell Lung - pathology
/ Female
/ Humans
/ Lung Neoplasms - drug therapy
/ Male
/ Non-small cell lung carcinoma
/ Patients
/ Protein Kinase Inhibitors - adverse effects
/ Protein Kinase Inhibitors - therapeutic use
/ Protein-Tyrosine Kinases - antagonists & inhibitors
/ Protein-Tyrosine Kinases - genetics
/ Proto-Oncogene Proteins - genetics
/ Proto-Oncogene Proteins - metabolism
/ Tissues
