Guardant Health, Inc. · NASDAQ:GH
Guardant Health — American Association for Cancer Research Annual Meeting 2019
11 slides from Guardant Health's conference presentation, Apr 2, 2019
Slide 1: Clinical utility of comprehensive cfDNA analysis to identify genomic biomarkers in newly diagnosed mNSCLC
Clinical utility of comprehensive cell-free DNA (cfDNA) analysis to identify genomic biomarkers in newly diagnosed metastatic non-small cell lung cancer (mNSCLC) Natasha B. Leighl, Ray D. Page, Victoria M. Raymond, Davey B. Daniel, Stephen Divers, Karen Reckamp, Miguel A. Villalona-Calero, Daniel Di
Slide 2: Disclosures
Disclosures • Advisory board: Nektar Therapeutics, AstraZeneca, Arrys Therapeutics, Merck, LOXO Oncology, Araxes Pharma, F Hoffman-La Roche, Janssen Research Foundation, Bristol- Myers Squibb, Clovis Oncology, Eli Lilly, Novartis, Takeda, Abbvie, TRM Oncology, Tesaro, Exelixis, Nektar, Gritstone, Ar
Slide 3: Background
Background • Clinical practice guidelines advocate for genotyping in all patients with newly diagnosed metastatic non-small cell lung cancer (mNSCLC) • There is general consensus across guidelines that alterations in up to 7 genes need to be assessed to appropriately guide treatment with FDA approve
Slide 4: Methods
Methods • Between July 2016 and April 2018, patients with newly diagnosed non-squamous mNSCLC, undergoing physician discretion SOC tissue genotyping were prospectively recruited from 28 North American centers • Patients underwent cfDNA testing utilizing a validated clinically available assay Leighl
Slide 5: Study Cohort
Percentage Number (%) Study Cohort Gender Female Male 153 129 54.3 45.7 Median Age at diagnosis (range) in years 69 (26 – 100) Asian 17 6.0 Patients consented Black or African American 18 6.4 (N = 307) Native Hawaiian or other No pre-treatment Pacific Islander 1 0.4 Race cfDNA sample White 231 81.9
Slide 6: Results – Guideline Complete Genomic Testing for all 8 Biomarkers
Results – Guideline Complete Genomic Testing for all 8 Biomarkers • cfDNA testing results in significantly more Percentage of patients with completed tissue assessment for the guideline-recommended biomarkers patients with guideline complete genotyping (p<0.0001) 100% • 95% (268/282) had guideline c
Slide 7: Results – cfDNA Biomarker Detection Rate
Results – cfDNA Biomarker Detection Rate • Primary endpoint of cfDNA non-inferiority was met, with physician discretion SOC tissue genotyping identifying 60 patients (21.3%) with a guideline recommended biomarker and cfDNA identifying 77 patients (27.3%) (p<0.0001 for non-inferiority) Tissue Guideli
Slide 8: Results – cfDNA Concordance and Positive Predictive Value
Results – cfDNA Concordance and Positive Predictive Value FDA Approved Tissue Not Targets Tissue + Tissue - Total Assessed/ QNS • For genes with FDA-approved cfDNA+ 18 0 1 19 Sensitivity 81.8% targeted therapy (EGFR, ALK, EGFR Exon 19 del cfDNA- 4 201 44 249 PPV 100.0% ROS1, and BRAF) cfDNA cancelle
Slide 9: Results – cfDNA Testing versus Tissue Testing First
Results – cfDNA Testing versus Tissue Testing First • Utilizing tissue testing first would have identified 67% of the 89 patients with a guideline-recommended biomarker Percentage of Guideline-Recommended Biomarker Positive • 33% of patients identified on reflex cfDNA Patients Identified by Tissue v
Slide 10: Conclusions
Conclusions • This prospective study demonstrates that utilization of a validated, comprehensive, and sensitive cfDNA test in newly diagnosed mNSCLC patients successfully identifies guideline recommended biomarkers at a rate similar to physician discretion standard of care tissue testing • Concordan
Slide 11: Acknowledgements
Acknowledgements • NILE Study Sites: Texas Oncology Millennium Oncology The Center for Cancer and Blood Disorders Dignity Health Research Institute Lancaster Cancer Center City of Hope Vista Oncology Princess Margaret Cancer Centre Genesis Cancer Center Ventura County Hematology-Oncology Specialists
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