Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial
Journal
Nature medicine
Journal Volume
30
Journal Issue
7
Start Page
1923
End Page
1932
ISSN
1546-170X
Date Issued
2024-07
Author(s)
Peters, Solange
Gadgeel, Shirish M
Mok, Tony
Nadal, Ernest
Kilickap, Saadettin
Swalduz, Aurélie
Cadranel, Jacques
Sugawara, Shunichi
Chiu, Chao-Hua
Moskovitz, Mor
Tanaka, Tomohiro
Nersesian, Rhea
Shagan, Sarah M
Maclennan, Margaret
Mathisen, Michael
Bhagawati-Prasad, Vijay
Diarra, Cheick
Assaf, Zoe June
Archer, Venice
Dziadziuszko, Rafal
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 .
Type
journal article