Findings from NILE Study - Guardant Health AMEA

NILE Study: Large prospective head-to-head trial finds Guardant360^® is as effective as tissue testing in detecting NSCLC biomarkers¹

Key Findings

Agreement between Guardant360^® and tissue testing was greater than 90% for the four biomarkers with FDA-approved therapies at the time of the study.
Guideline-recommended biomarker testing was completed for 95% of patients with Guardant360^® vs 32% with standard-of-care tissue testing at the time of the study.
Turnaround time was 6 days faster with Guardant360^® vs. SOC tissue testing at the time of the study.

Key Findings

Agreement between Guardant360^® and tissue testing was greater than 90% for the four biomarkers with FDA-approved therapies at the time of the study.
Guideline-recommended biomarker testing was completed for 95% of patients with Guardant360^® vs 32% with standard-of-care tissue testing at the time of the study.
Turnaround time was 6 days faster with Guardant360^® vs. SOC tissue testing at the time of the study.

“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

Study Overview

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

Study Overview

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

Points for your practice

Guardant360^® performed similarly to tissue in the detection of guideline-recommended biomarkers

Guardant360^® performed similarly to tissue in the detection of guideline-recommended biomarkers

Guardant360 enabled more complete biomarker assessment than tissue testing

Faster test results and less time waiting to make treatment decisions

Guardant360^® provided test results in 9 days vs 15 days for tissue

Faster test results and less time waiting to make treatment decisions

Guardant360^® provided test results in 9 days vs 15 days for tissue

Guardant360^® detects more guideline-recommended biomarkers** than tissue testing

** EGFR mutations, ALK fusions, ROS1 fusions, BRAF V600E mutation, RET fusions, MET amplification and MET exon 14 skipping variants, and ERBB2 (HER2) mutations.

Guardant360^® detects more guideline-recommended biomarkers** than tissue testing

** EGFR mutations, ALK fusions, ROS1 fusions, BRAF V600E mutation, RET fusions, MET amplification and MET exon 14 skipping variants, and ERBB2 (HER2) mutations.

NILE Study Review

Dr. Vassiliki A. Papadimitrakopoulou,
MD Anderson Cancer Center

Reference:
1. Leighl NB et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer, Clin Cancer Res. 2019
MKTAMEA112020_015

NILE Study: Large prospective head-to-head trial finds Guardant360^® is as effective as tissue testing in detecting NSCLC biomarkers¹

Key Findings

Agreement between Guardant360^® and tissue testing was greater than 90% for the four biomarkers with FDA-approved therapies at the time of the study.
Guideline-recommended biomarker testing was completed for 95% of patients with Guardant360^® vs 32% with standard-of-care tissue testing at the time of the study.
Turnaround time was 6 days faster with Guardant360^® vs. SOC tissue testing at the time of the study.

Key Findings

Agreement between Guardant360^® and tissue testing was greater than 90% for the four biomarkers with FDA-approved therapies at the time of the study.
Guideline-recommended biomarker testing was completed for 95% of patients with Guardant360^® vs 32% with standard-of-care tissue testing at the time of the study.
Turnaround time was 6 days faster with Guardant360^® vs. SOC tissue testing at the time of the study.