Guardant Health to Present New Data from its Broad Portfolio of Blood Tests at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

• Oral presentation in Clinical Science Symposium will demonstrate use of real-world data from GuardantINFORM to identify resistance to early treatment in advanced breast cancer
• Oral presentation in Breast Cancer-Metastatic Session will highlight updated progression-free survival data of fulvestrant plus capivasertib versus fulvestrant plus placebo in metastatic breast cancer using enhanced biomarker analysis

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today it will present new data at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 in Chicago. Among the 19 abstracts are oral presentations highlighting the use of real-world data to identify resistance to early treatment in advanced breast cancer and the use of enhanced biomarker analysis to evaluate progression-free survival data in metastatic breast cancer therapy.

“We look forward to sharing an array of robust data at ASCO that demonstrate the utility of our blood tests to help healthcare professionals optimize care for patients at all stages of the disease—from detecting early-stage cancers to identifying the presence of residual disease and delivering insights that inform treatment to improve outcomes,” said Helmy Eltoukhy, Guardant Health co-CEO. “We’ll be presenting data from retrospective and real-world analyses that show how blood-based tests provide critical insights at every step of a patient’s treatment journey, and analytics that contribute to the broader scientific community’s understanding of some of the most challenging cancers.”

Full List of Guardant Health Presentations

Guardant360

• Circulating tumor DNA profiling and serial analysis in salivary gland carcinomas reveal unique mutational subsets and actionable alterations (Abstract 6097)
• Co-occurring alterations across molecular pathways in metastatic colorectal cancer (mCRC) (Abstract 3590)
• Characterization of genomic landscape using comprehensive circulating cell-free tumor DNA next generation sequencing in advanced thyroid carcinoma (Abstract 3045)
• Using cell-free circulating tumor DNA (cfDNA) to identify guideline-relevant biomarkers for therapy selection in 14,000 patients (pts) with metastatic colorectal cancer (mCRC) (Abstract 3601)
• Prevalence of incidental pathogenic germline variants detected in cfDNA in patients with oncogene-driven non-small cell lung cancer (Abstract 10569)
• KIT resistance mutations identified by circulating tumor DNA and treatment outcomes in advanced gastrointestinal stromal tumor (Abstract 11514)
• RAS co-mutation and early onset disease represent an aggressive phenotype of atypical (non-V600) BRAF mutant metastatic colorectal cancer (Abstract 3592)
• Variation in liquid biopsy cfDNA yield predicted by somatic mutation and clinical phenotypes across primary cancers (Abstract 13553)
• Circulating tumor DNA profile in pancreatic ductal adenocarcinoma (PDAC) and potential targeted therapy (Abstract 4152)
• Phase 3 trial of lorlatinib in treatment-naïve patients (Pts) with ALK-positive advanced non-small cell lung cancer (NSCLC): Comprehensive plasma and tumor genomic analyses (Abstract 9070)

Guardant Reveal

• Clinician utilization of a plasma-only, multiomic minimal residual disease (MRD) assay in 2,000 consecutive patients with colorectal cancer (CRC) (Abstract 15586)

Guardant360 Response

• Circulating tumor DNA (ctDNA) in HER2 exon 20 insertion mutations and responses in NSCLC HER2 exon 20 insertion treated with poziotinib (Abstract 3051)
• Prognostic value of molecular response via ctDNA measurement in predicting response of systemic therapy in patients with advanced solid cancer (Abstract 13001)

GuardantINFORM

• Use of real-world data (RWD) to assess the utility of cell-free circulating tumor DNA (cfDNA) in identifying resistance to early treatment in advanced breast cancer (aBC) (Abstract 1011). Oral presentation during Clinical Science Symposium.

GuardantOMNI

• Fulvestrant plus capivasertib versus fulvestrant plus placebo after relapse or progression on an aromatase inhibitor in metastatic, estrogen receptor-positive breast cancer (FAKTION): Overall survival and updated progression-free survival data with enhanced biomarker analysis (Abstract 1005). Oral presentation during Metastatic Breast Cancer session.
• Serena-1: Updated analyses from a phase 1 study (parts C/D) of the next-generation oral SERD camizestrant (AZD9833) in combination with palbociclib, in women with ER-positive, HER2-negative advanced breast cancer (Abstract 1032)

Shield LDT – CRC Screening

• Validation of a multi-modal blood-based test for the detection of colorectal cancer with sub single molecule sensitivity (Abstract 3627)

Next generation Shield – Multi-Cancer Screening

• Development of a highly-sensitive targeted cell-free DNA epigenomic assay for integrated screening of lung and colorectal cancer (Abstract 3542)
• Trial in progress: Screening for high frequency malignant disease (SHIELD) (Abstract TPS1602)

The full abstracts will be available on the official ASCO website on May 26, 2022.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, 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. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2021 and in its other reports filed 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 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.

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