Clinical Cancer Research
NILE Study: Large prospective head-to-head trial finds Guardant360® is as effective as tissue testing in detecting NSCLC biomarkers.
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
May 1, 2020
“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
Concordance to Tissue
Includes the 4 biomarkers with FDA-approved therapies: EGFR, ALK, ROS1, BRAF
Guardant360 enabled more complete biomarker assessment than tissue testing
Faster test results and less time waiting to make treatment decisions
Guardant360-first testing finds more patients than tissue-first testing
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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
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
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
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.
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
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