JAMA Oncology
Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non-Small Cell Lung Cancer.
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
Oct 11, 2018
“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
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
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 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 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 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
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