JAMA Oncology

Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non–Small Cell Lung Cancer.

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Published in JAMA Oncology, this large, prospective study enrolled 323 patients with advanced NSCLC and concluded that routine use of Guardant360® can increase the likelihood of finding targetable mutations.25

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Oct 11, 2018


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These results, combined with the patient satisfaction with the relative ease of providing blood rather than a solid tissue sample, suggest a clinical strategy of pursuing plasma NGS first, then tissue NGS if plasma NGS cannot detect relevant mutations.”

Bishal Gyawali, MD, PhD;
Howard (Jack) West, MD

Editorial

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

90 Percent

Concordance with tissue genotyping for targetable alterations before first line NSCLC therapy25

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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 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 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 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

Learn More

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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