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Guardant360 Performance Matches Standard-of-Care Tissue Testing in First-Line, Advanced Non-Small Cell Lung Cancer, NILE Study Shows, Meeting Primary Endpoint

Head-to-Head Comparison to be Presented at AACR Supports Use of “Blood First” For First-Line Advanced NSCLC Patients

REDWOOD CITY, Calif., Feb. 27, 2019 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (GH), announced positive results from the NILE study, a head-to-head comparison of the Guardant360® assay to standard-of-care tissue testing for the identification of guideline-recommended biomarkers in first-line advanced non-small cell lung cancer (NSCLC) patients. These landmark data show that Guardant360 detected targetable genomic biomarkers at a similar rate to tissue and support the use of blood-based biomarker testing ahead of tissue-based testing for all newly diagnosed advanced NSCLC patients.

“Given this assay finds mutations at a similar rate to tissue-based testing, while ensuring patients receive guideline-complete testing with a faster turn-around time, it’s a compelling option to use liquid first ahead of tissue for molecular testing in newly diagnosed advanced NSCLC,” said Vassiliki Papadimitrakopoulou, MD, Chief Section of Thoracic Medical Oncology, MD Anderson Cancer Center and the study’s senior author.

Investigators found that Guardant360 identified guideline recommended-biomarkers in 77 patients; tissue testing identified them in 60. Importantly, for each patient in whom Guardant360 identified a target of an FDA-approved drug (EGFR, ALK, BRAF, ROS1), tissue also detected the same alteration. Additionally, the median time to results for Guardant360 was much shorter than for tissue testing. Guardant360 results were reported in an average of 9 days, versus 15 days for tissue. The NILE study met its primary endpoint of demonstrating comparable performance of Guardant360 to tissue.

“This is an important new data set for clinical oncologists that we believe will further accelerate adoption of Guardant360 and, taken together with other recent independent investigations into Guardant360 in this clinical setting, solidifies the case for using blood first for treatment selection,” said Helmy Eltoukhy, PhD, Guardant Health’s Chief Executive Officer.

Study Details

The NILE, or “Noninvasive versus Invasive Lung Evaluation” study is a prospective, multi-center study of 282 newly-diagnosed, advanced NSCLC patients. Each patient was tested with Guardant360 and the physician’s choice of tissue-based testing. Results of the tests were compared for the detection of the guideline-recommended biomarkers important for treatment selection: EGFR, ALK, BRAF, RET, ROS1, MET, and ERBB2. Knowing the status of these guideline-recommended biomarkers is important before beginning treatment because up to 30 percent of patients can be treated with targeted therapies that often have higher response rates than chemotherapy or immunotherapy.

Dr. Papadimitrakopoulou will present the results at the AACR Annual Meeting during the Molecular and Cell-Based Circulating Biomarkers to Guide Optimal Anticancer Treatment Session, April 2, 2019 from 3-5 p.m. Eastern.

Additional AACR Presentations

In addition to the NILE study, Guardant Health researchers contributed to the following presentations and posters at AACR, including an investigation of the performance of the company’s LUNAR assay on Sunday March 31. Abstracts are available on AACR’s website at https://www.abstractsonline.com/pp8/#!/6812.

Genomic and epigenomic assessment of cell-free circulating tumor DNA (ctDNA) improves assay sensitivity in early stage colorectal cancer (CRC). This abstract is being presented in an oral presentation on March 31, 3 p.m. - 5 p.m. (Abstract 4270)

COLOMATE: Colorectal Cancer and Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy​. This abstract is being presented as an oral presentation. (Abstract 7915)

Cell-free circulating tumor DNA (ctDNA) detects somatic copy number loss in homologous recombination repair (HRR) genes. This abstract is being presented as a poster on March 31, 1 p.m. - 5 p.m. (Abstract 435)

Novel genomic differences in cell-free circulating tumor DNA (cfDNA) profiles of early versus older onset colorectal cancer (CRC). This abstract is being presented as a poster on March 31, 1 p.m. - 5 p.m. (Abstract 450)

Analytical validation of MSI High detection with GuardantOMNI. This abstract is being presented as a poster on April 1, 8 a.m. - 12 p.m. (Abstract 1675)

Analysis of clonal hematopoiesis-associated mutations in the cell-free DNA of advanced cancer patients. This abstract is being presented as a poster on April 1, 1 p.m. - 5 p.m. (Abstract 2509)

Resistance to TRK Inhibition Mediated by Convergent MAP Kinase Pathway Activation. This abstract is being presented as a poster on April 1, 1 p.m. - 5 p.m. (Abstract LB-118)

Use of comprehensive cell-free circulating tumor DNA (cfDNA) analysis to identify genomic biomarkers in newly diagnosed advanced non-small cell lung cancer (NSCLC) patients (pts). This abstract is being presented as a poster on April 1, 1 p.m. - 5 p.m. (Abstract 2509)

Landscape and genomic correlates of ctDNA-based Tumor Mutational Burden across six solid tumor types. This abstract is being presented as a poster on April 2, 8 a.m. - 12 p.m. (Abstract 3404)

Detection of allele specific loss of heterozygosity in 70,000 patients with ctDNA. This abstract is being presented as a poster on April 2, 1 p.m. - 5 p.m. (Abstract 3769)

About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.  Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.  In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, such as statements about the expected impact of the NILE study data. Such statements reflect Guardant Health’s current expectations, forecasts and assumptions. Actual results may vary materially from forward-looking statements due to risks, uncertainties and other factors, known and unknown to Guardant Health as of the date hereof, such as those discussed in Guardant Health’s filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in its Quarterly Report for the period ended September 30, 2018 and in its subsequent filings with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Guardant Health disclaims any obligation to update any forward-looking statements, except as required by law.

Investor Contact:
Lynn Lewis or Carrie Mendivil
investors@guardanthealth.com

Media Contact:
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