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Blood First Assay Screening Trial (BFAST) in Treatment-Naive Advanced or Metastatic NSCLC : Initial Results of the Phase 2 ALK-Positive Cohort

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Abstract
Introduction: The Blood First Assay Screening Trial is an ongoing open-label, multicohort study, prospectively evaluating the relationship between blood-based next -generation sequencing (NGS) detection of actionable genetic alterations and activity of targeted therapies or immunotherapy in treatment-naive advanced or metastatic NSCLC. We present data from the ALK-positive cohort. Methods: Patients aged more than or equal to 18 years with stage IIIB or IV NSCLC and ALK rearrangements detected by blood-based NGS using hybrid capture technology (FoundationACT) received alectinib 600 mg twice daily. Asymptomatic or treated central nervous system (CNS) metastases were permitted. Primary end point was investigator-assessed objective response rate (ORR; Response Evaluation Criteria in Solid Tumors version 1.1). Secondary end points were independent review facility-assessed ORR, duration of response, progression-free survival (PFS), overall survival, and safety. Exploratory end points were investigator-assessed ORR in patients with baseline CNS metastases and relationship between circulating biomarkers and response. Results: In total, 2219 patients were screened and blood based NGS yielded results in 98.6% of the cases. Of these, 119 patients (5.4%) had ALK-positive disease; 87 were enrolled and received alectinib. Median follow-up was 12.6 months (range: 2.6-18.7). Confirmed ORR was 87.4% (95% confidence interval [CI]: 78.5-93.5) by investigator and 92.0% (95% CI: 84.1-96.7) by independent review facility. Investigator-confirmed 12-month duration of response was 75.9% (95% CI: 63.6-88.2). In 35 patients (40%) with baseline CNS disease, investigator-assessed ORR was 91.4% (95% CI: 76.9-98.2). Median PFS was not reached; 12-month investigator-assessed PFS was 78.4% (95% CI: 69.1-87.7). Safety data were consistent with the known tolerability profile of alectinib. Conclusions: These results reveal the clinical application of blood-based NGS as a method to inform clinical decision making in ALK-positive NSCLC. (c) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Author(s)
이대호Daniel S W TanDavid S ShamesErica SchleifmanErnest NadalFilippo de MarinisGilberto de Castro JuniorHye Ryun KimJi-Youn HaJorge Alatorre-AlexanderMark YanMaurice PerolMichael S MathisenNatasha LeighlOsvaldo Aren FronteraRafal DziadziuszkoRajesh PatelSarah M PaulShirish M Gadge
Issued Date
2021
Type
Article
Keyword
ALK-positiveAlectinibBlood-based assayNSCLCNext-generation sequencing.
DOI
10.1016/j.jtho.2021.07.008
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8453
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2555636978&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Blood%20First%20Assay%20Screening%20Trial%20(BFAST)%20in%20Treatment-Naive%20Advanced%20or%20Metastatic%20NSCLC%20:%20Initial%20Results%20of%20the%20Phase%202%20ALK-Positive%20Cohort&offset=0&pcAvailability=true
Publisher
JOURNAL OF THORACIC ONCOLOGY
Location
미국
Language
영어
ISSN
1556-0864
Citation Volume
16
Citation Number
12
Citation Start Page
2040
Citation End Page
2050
Appears in Collections:
Medicine > Medicine
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