Clinical Cancer Research

NILE Study: Large prospective head-to-head trial finds Guardant360® is as effective as tissue testing in detecting NSCLC biomarkers.

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A head-to-head, prospective, multicenter trial compared Guardant360 vs. standard-of-care tissue testing for biomarker detection in 282 newly-diagnosed patients with advanced NSCLC.24

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May 1, 2020


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In a landscape where a large fraction of our patients never get their tumor genotyped because of insufficient tissue or sequential tissue testing, it would make sense to adopt a strategy where blood is used first to detect alterations.”

Dr. Vassiliki A. Papadimitrakopoulou
Department of Thoracic Head and Neck Medical Oncology
, MD Anderson Cancer Center

Key Findings24

  • Concordance between Guardant360 and tissue testing was greater than 90% for the four biomarkers with FDA-approved therapies
  • Guideline-recommended biomarker testing was completed for 95% of patients with Guardant360 vs 31% with standard-of-care tissue testing
  • Turnaround time was ~1 week faster with Guardant360 vs SOC tissue testing

Clinical Summary

Guardant360 LDT performed similarly to tissue in the detection of guideline-recommended biomarkers

Greater than 90%

Concordance to Tissue

Includes the 4 biomarkers with FDA-approved therapies: EGFR, ALK, ROS1, BRAF

Guardant360 enabled more complete biomarker assessment than tissue testing

Guardant360 tested 95% of patients for the 4 biomarkers with FDA-approved therapies vs 31% with tissue.

Faster test results and less time waiting to make treatment decisions

7 day faster median turnaround time with Guardant360 vs tissue testing

Guardant360-first testing finds more patients than tissue-first testing

20% more patients with biomarkers detected using Guardant360 first

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Key Findings26

  • The demands on tissue specimens from diagnostic stains and PD-L1 testing may leave little remaining for genomic profiling
  • Gaps in genomic biomarker testing can be overcome with new technologies

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Key Findings27

  • Comprehensive ctDNA testing can effectively guide therapy selection
  • Response rates to therapy selected based on Guardant360 results were consistent with those in tissue-based targeted therapy studies

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Key Findings19

  • Guardant360 detects guideline-complete alterations in advanced NSCLC patients, including MET exon 14 skipping alterations
  • ORR and DCR equivalent in Guardant360 and tissue biopsy groups in the VISION trial MET exon 14 skipping NSCLC cohort

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Key Findings

  • In the NSCLC cohort, 32.2% (19 patients) had a confirmed objective response (complete or partial response) and 88.1% (52 patients) had disease control (objective response or stable disease).
  • The median progression-free survival was 6.3 months.

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Key Findings24

  • Concordance between Guardant360 and tissue testing was greater than 90% for the four biomarkers with FDA-approved therapies
  • Guideline-recommended biomarker testing was completed for 95% of patients with Guardant360 vs. 31% with standard-of-care tissue testing
  • Turnaround time was ~1 week faster with Guardant360 vs. SOC tissue testing

Learn More

Key Findings25

  • 44% of eligible patients were unable to get complete genomic results from tissue biopsy
  • 2x as many patients had targetable alterations detected by Guardant360 and tissue testing (n=82) versus tissue testing alone (n=47)
  • 86% of patients had a response or stable disease based on RECIST criteria

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