Press Release

May 15, 2020

Guardant Health Data at ASCO and AACR Demonstrates Growing Value of Liquid Biopsy for Precision Oncology in Advanced and Early Stage Cancer

REDWOOD CITY, Calif., May 15, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) along with leading academic institutions and pharmaceutical companies will present data highlighting the use of the company’s proprietary blood tests to advance precision oncology across the continuum of care at the upcoming 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, being held from May 29-31; and the AACR Virtual Annual Meeting II, scheduled for June 22-24.

More than 25 abstracts, now online, demonstrate how blood-based comprehensive genotyping is integral to the adoption of precision oncology in advanced cancer. The data highlights the use of Guardant360 and GuardantOMNI liquid biopsy tests to detect clinically actionable mutations and to help inform treatment for patients as their cancer progresses.  Key findings demonstrate high concordance with tissue biopsies, the advantages over tissue biopsies to detect clinically relevant mutations for rule-in and rule-out decisions, and feasibility of serial testing from patient plasma to reveal tumor evolution and resistance in response to intervening therapies, including immunotherapies. Additionally, researchers will present data indicating the effectiveness of new targeted therapies.

“Now more than ever, liquid biopsies can help overcome the barriers of tissue biopsies that this pandemic has either exacerbated or created for the most vulnerable of patients. The data presented at ASCO and AACR will further demonstrate the advantages of blood-based comprehensive genotyping to reveal critical genomic information that will improve the management of advanced cancer,” said Helmy Eltoukhy, Guardant Health co-founder and CEO. “We also look forward to sharing LUNAR-2 data demonstrating improved performance of our liquid biopsy in detecting early-stage colorectal cancer, and the progress of LUNAR-1 trials currently underway.”

LUNAR-2 Liquid Biopsy Demonstrates Improved Performance in Detecting Early-Stage Colorectal Cancer

AACR data shows improved performance of the LUNAR-2 liquid biopsy to detect early-stage colorectal cancer (CRC) in average-risk adults.  In a blinded cohort analysis of colonoscopy screened negative patients (n=88) and patients newly diagnosed with early stage CRC (n=113) using a further optimized, integrated genomic and epigenomic analysis, the LUNAR-2 assay demonstrated overall sensitivity of 90.3% and overall specificity of 96.6%, representing a slight improvement over previously reported data.

Guardant360 Clinical-Genomic Dataset Highlights Value of Liquid Biopsy for Precision Oncology Drug Development

AACR data quantifies the value of Guardant Health’s clinical-genomic real-world evidence (RWE) dataset, GuardantINFORM, to enable drug development using circulating tumor DNA (ctDNA) as an alternative to serial tissue testing.  In a cohort of patients who underwent Guardant360 serial ctDNA testing (n=85,874) and linked to de-identified medical and pharmacy claims, a robust longitudinal view of the patients’ diagnosis, treatments, and clinical outcomes was accessible for a majority of patients.  The availability of clinical-genomic information following systemic therapy confirms that this dataset could serve as a viable resource for precision oncology drug development researchers to evaluate drug resistance and tumor evolution in a real-world setting.

Trials Underway Validating LUNAR-1 Liquid Biopsy to Inform Adjuvant Treatment for Colon Cancer

ASCO data highlights the status of two prospective, multi-center clinical trials validating the clinical utility of the LUNAR-1 liquid biopsy to guide adjuvant treatment decisions for colon cancer.

  • NRG-G1005 COBRA Study/Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Stage II Colon Cancer (NCT04068103)
  • PEGASUS Trial/Post-Surgical Liquid Biopsy-Guided Treatment of Stage III and High-Risk Stage II Colon Cancer Patients (NCT04259944)

Presentations at ASCO and AACR

ASCO 2020 Annual Meeting

Abstract # Title
Guardant360 
105

Utility of circulating cell-free DNA (cfDNA) analysis in patients with carcinoma of unknown primary (CUP) in identifying alterations with strong evidence for response or resistance to targeted therapy. 
9523 Prevalence and association of ARID1A with driver alterations and immune checkpoint inhibitor (ICPi) biomarkers in cell-free circulating tumor DNA (ctDNA) from 27,000 non-small cell lung cancer (NSCLC) patients.
9532 Residual circulating tumor DNA (ctDNA) after two months of therapy to predict progression-free and overall survival in patients treated on S1403 with afatinib +/- cetuximab.
9553 Clinical performance of a comprehensive novel liquid biopsy test for identifying non-small cell lung cancer (NSCLC) patients for treatment with osimertinib.
9601 ctDNA resistance landscape of lazertinib, a third-generation EGFR tyrosine kinase inhibitor.
9603 Longitudinal monitoring by next generation sequencing of plasma cell-free DNA in ALK-rearranged non-small cell lung cancer (NSCLC) patients treated with ALK tyrosine kinase inhibitors.
e21502 Real-world data on liquid biopsies utilization In lung cancer patients in the community setting: The Mount Sinai experience.
3546 Demonstrating value of liquid biopsy for lung cancer in a public healthcare system.
3547 The prevalence of KRAS G12C mutations utilizing circulating tumor DNA (ctDNA) in 80,911 patients with cancer.
1031 Identification of pathogenic ROS1 alterations in cell-free DNA (cfDNA) from patients with breast cancer.
1089 Mutation profile differences in younger and older patients with advanced breast cancer using circulating tumor DNA (ctDNA).
4559 Pembrolizumab with trastuzumab and chemotherapy (PTC) in HER2-positive metastatic esophagogastric cancer (mEG): plasma and tumor-based biomarker analysis.
10059 Clinical outcomes in patients with BRAF V600 mutant melanoma and undetectable circulating cell-free tumor DNA treated with dabrafenib and trametinib. 
e17594 Prognostic implications of gene amplifications identified by circulating tumor DNA (ctDNA) analysis in metastatic prostate cancer (mPC).
e17597 Identification of actionable BRAF mutations and their genomic associations in advanced prostate cancer.
4071 Utility of circulating tumor DNA (ctDNA) versus tumor tissue genotyping for enrollment of patients with metastatic colorectal cancer (mCRC) to matched clinical trials: SCRUM-Japan GI-SCREEN and GOZILA combined analysis.
3516 Utility of circulating tumor DNA (ctDNA) versus tumor tissue clinical sequencing for enrolling patients (pts) with advanced non-colorectal (non-CRC) gastrointestinal (GI) cancer to matched clinical trials: SCRUM-Japan GI-SCREEN and GOZILA combined analysis. 
LUNAR-1 Trials in Progress
TPS4121
Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA).
TPS4124 The PEGASUS trial: Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients.

AACR Virtual Meeting II

Abstract # Title
LUNAR-2
2316 Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer.
GuardantOMNI
1992 Improved somatic classification and detection of tumor heterogeneity using ctDNA based liquid biopsy compared to tumor-only tissue in colorectal cancer.
Guardant360: Clinical-Genomic Dataset
4421 Development of a clinical-genomic database to study tumor evolution and molecular biomarkers of drug resistance in a real-world setting. 
Guardant360
LB-063 ARID1A mutations induce an EGFR-like gene expression signature and confer intrinsic and acquired resistance to cetuximab treatment in first line metastatic CRC.
787

Comparable clinical benefits between low and high variant allelic frequency in NSCLC patients treated with targeted therapies based on molecular alterations from ctDNA NGS.
217 Mutational exclusivity and mutational co-occurrence observed in advanced cancer liquid biopsy.
836 Liquid biopsy wild type prediction of negative predictors for anti-EGFR therapy in advanced colorectal cancer (CRC).
729 Landscape of homologous recombination repair (HRR) mutations in prostate cancer profiled by ctDNA next-generation sequencing.
734 Monitoring of dynamic changes and clonal evolution in circulating tumor DNA from patients with IDH-mutated cholangiocarcinoma treated with IDH inhibitors.

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. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential benefits and advantages of Guardant Health’s liquid biopsy tests or assays as well as its clinical-genomic dataset, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in its other reports filed with the Securities and Exchange Commission. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

Investor Contact:
Carrie Mendivil
investors@guardanthealth.com

Media Contact:
Anna Czene
press@guardanthealth.com

Becky Lauer
becky.lauer@uncappedcommunications.com

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Source: Guardant Health, Inc.