Journal of Clinical Oncology

Prospective Feasibility Study for Using Cell-Free Circulating Tumor DNA-Guided Therapy in Refractory Metastatic Solid Cancers: An Interim Analysis.

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In this prospective analysis of 194 advanced cancer patients profiled with the Guardant360® assay, the response rate and disease control rate were 87% and 100%, respectively, in patients with NSCLC-received, molecularly-matched therapy.27

Sep 11, 2020


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Among patients with insufficient tumor tissue for sequencing, ctDNA testing can be a feasible option to guide molecularly matched therapy.”

Seung Tae Kim, MD

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

Clinical Summary

Next-2: Guardant360 LDT-based master protocol clinical utility trial, August 2014 - June 2016. This prospective study demonstrated the clinical utility of using ctDNA to guide treatment selection in advanced cancer patients. Nearly a quarter (23%) of patients in the NSCLC cohort were matched to targeted therapy.

NSCLC Cohort Waterfall Plot. Response was independent of targeted alteration variant allele fraction in NSCLC (P = .63). Objective response was achieved even at low variant allele fraction

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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

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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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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 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

Learn More