Business Wire | Jun 18, 2021 07:57PM EDT

CORRECTING and REPLACING Guardant Health Presents Data at 2021 ASCO Annual Meeting Showing Utility of Liquid Biopsy in Early- and Late-Stage Cancers

Jun. 18, 2021

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jun. 18, 2021--Please replace the release dated May 19, 2021 with the following corrected version due to a change in the fourth paragraph.

The updated release reads:

GUARDANT HEALTH PRESENTS DATA AT 2021 ASCO ANNUAL MEETING SHOWING UTILITY OF LIQUID BIOPSY IN EARLY- AND LATE-STAGE CANCERS

Data from 20 abstracts demonstrate value of company's blood tests across the continuum of cancer care, including: screening, therapy selection, residual and recurrent disease detection, and biopharmaceutical drug development

Guardant Health, Inc. (Nasdaq: GH), to present data demonstrating the use of the company's proprietary blood tests to advance precision oncology, including cancer screening, detecting residual or recurrent disease in early-stage cancer, and treatment selection and treatment response monitoring in advanced cancer. Data, from 20 abstracts, will be presented along with other leading medical institutions and pharmaceutical companies, during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held from June 4-8, 2021.

"The data at ASCO not only demonstrate the advantages of blood-based comprehensive genomic profiling in advanced cancer, but also the growing body of evidence showing the power of our blood tests across the continuum of care. We are pleased to share data that not only informs treatment decisions, but that also shows value in assessing treatment response, screening for early-stage colorectal cancer in asymptomatic patients, and detecting residual or recurrent disease in early-stage cancers, including colorectal, non-small cell lung, and bladder," said Helmy Eltoukhy, Guardant Health CEO. "The data also illustrates the value of our liquid biopsy tests and our real-world clinical-genomic platform to gain new insights which help accelerate research and development of the next generation of cancer therapeutics."

LUNAR-2 Blood Test Detects Early-Stage Colorectal Cancer (CRC) with High Accuracy in Largest Cohort to Date

The data (N=705) show that the LUNAR-2 assay achieved overall sensitivity of 91% in early-stage CRC (stage I, II, and III), and specificity of 94%. The performance in this new large cohort of CRC cases, and cancer-free controls, is consistent with previously reported data.1-2 Notably no differences in sensitivity for CRC detection were observed in patients presenting with asymptomatic disease, compared to those patients who were symptomatic, despite the lower cell-free DNA (cfDNA) tumor fractions observed in asymptomatic patients, suggesting the test will have clinically meaningful performance in an average-risk screening population (Abstract 3536).

Guardant Reveal(tm) Blood Test Detects ctDNA in Early-Stage Non-Small Cell Lung and Bladder Cancers, and Predicts Recurrence in Oligometastatic CRC in Post-Surgical Setting

The data show that Guardant Reveal, a first of its kind, blood-only minimal residual disease (MRD) test for solid tumors, detects circulating tumor DNA (ctDNA) in pre-treatment, early-stage non-small cell lung cancer and bladder cancer, without the need for tumor tissue, and with excellent performance (Abstract 3045).

Additionally, in a study (Abstract 3565) with the University of California San Francisco (UCSF) and Massachusetts General Hospital, the Guardant Reveal test detected MRD in patients with oligometastatic colorectal cancer undergoing curative intent surgery or radiotherapy. Detection of ctDNA post-procedure had a high positive predictive value (PPV) for cancer recurrence, with a median lead time of six months compared to surveillance imaging.

Guardant Health will also provide an update on the COBRA interventional trial (NRG-G1005: Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Stage II Colon Cancer) (Abstracts TPS3622, TPS148).

The Guardant Reveal test is commercially available for the detection of residual and recurrent disease in early-stage colorectal cancer. The test identifies patients with residual disease who may benefit most from adjuvant therapy, and has been shown to detect recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging. 3-8 The Guardant Reveal test achieves industry-leading sensitivity (91%) 9 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. Test results are obtained from a simple blood draw and returned in as little as seven days without the need for a tissue biopsy.

Guardant360(r) Blood Tests Demonstrate Clinical Utility in the Treatment and Management of Locally Advanced and Metastatic Cancers

Fifteen abstracts, now online, highlight the use of the Guardant360 test to detect clinically actionable mutations and to inform treatment options for patients. Key findings include data showing the ability of Guardant360 liquid biopsy to robustly detect tumor mutational burden across a wide range of solid tumors (Abstract 3040) and to predict clinical outcomes in a prospectively collected cohort of non-small cell lung cancer patients treated with targeted therapy (Abstract 9027). In addition, several abstracts highlight the ability of the Guardant360 test to predict molecular response in patients across a variety of cancer types and therapy classes (Abstract 4130, Abstract 9011).

GuardantINFORM(tm) Real-World Evidence Platform Used to Identify Unmet Need for Patients with Lung Adenocarcinomas Harboring STK11 and KRAS G12C Mutations Treated with Checkpoint Inhibitors

A study in collaboration with faculty from Massachusetts General Hospital and Mirati Therapeutics, Inc. (NASDAQ: MRTX) using clinical-genomic information from the GuardantINFORM platform demonstrated that patients with metastatic lung adenocarcinoma and co-occurring STK11 and KRASG12C mutations had significantly worse outcomes to treatment with first-line checkpoint inhibitor-based treatment regimens (including combination with platinum-based chemotherapy), highlighting the need for effective targeted and/or combination therapies to address this patient population (Abstract 9106).

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360(r) liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient's treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

Data at ASCO

Abstract# Title

LUNAR-2

Abstract No. Multimodal circulating tumor DNA (ctDNA) colorectal neoplasia3536 detection assay for asymptomatic and early-stage colorectal cancer (CRC)

Guardant RevealTm

Abstract No.3045 Multiomic, plasma-only ctDNA NGS assay for minimal residual disease (MRD) detection in solid tumors.

Abstract No. Circulating tumor derived cell-free DNA (ctDNA) to predict3565 recurrence of metastatic colorectal cancer (mCRC) following curative intent surgery or radiation.

Abstract No. Phase II/III study of circulating tumor DNA as a predictiveTPS3622, TPS148 biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-G1005 (COBRA).

Guardant 360^(r)

Abstract No. Blood-based tumor mutational burden from circulating tumor DNA3040 (ctDNA) across advanced solid malignancies using a commercially available liquid biopsy assay.

Abstract No. Clinical outcomes for plasma-based comprehensive genomic9027 profiling versus tissue testing in advanced lung adenocarcinoma.

Abstract No. Circulating cell free tumor DNA detection as a prognostic tool4130 in advanced pancreatic cancer.

Abstract No. Early circulating tumor DNA dynamics and efficacy of9011 lorlatinib: Analysis from the CROWN study.

Abstract No. Identification of pathogenic CDK12 alterations in cell-free1028 DNA (cfDNA) from patients with breast cancer.

Abstract No. Cell-free circulating tumor DNA (cfDNA) analysis of advanced8577 thymic epithelial tumors (TETs).

Abstract No. Circulating tumor DNA (ctDNA) in patients with advanced4585 adrenocortical carcinoma.

Abstract No. Genomic landscape differences in patients with advanced9108 non-small cell lung cancer by sex and age.

Abstract No. Circulating tumor DNA-based genomic profiling of small bowel3523 adenocarcinoma.

Abstract No. Serial ctDNA profiling in patients with metastatic prostatee17018 cancer undergoing treatment with Radium-223.

Abstract No. Serial circulating tumor DNA (ctDNA) monitoring in metastatic colorectal cancer (mCRC) reveals dynamic profile of actionable3572 alterations.

Abstract No. Complementary detection of genomic alterations in metastatic5038 castration?resistant prostate cancer (mCRPC) from CheckMate 9KD through analyses of tumor tissue and plasma DNA.

Assessment of HER2 (ERBB2) amplification (HER2amp) using blood-based circulating tumor DNA (ctDNA) next generationAbstract No. sequencing (NGS) and correlation with tissue-based testing in3589 metastatic colorectal cancer (mCRC)



Early predictors of benefit to dual anti-PD1/HER2 inhibition:Abstract No. Biomarker analysis from phase 2 trial of pembrolizumab/4058 trastuzumab in HER2-positive metastatic esophagogastric (mEG) cancer.

Pertuzumab plus trastuzumab and real-world standard of careAbstract No. (SOC) for patients (pts) with treatment refractory metastatic3555 colorectal cancer (mCRC) with HER2 (ERBB2) amplification (amp) confirmed by tumor tissue or ctDNA analysis.

GuardantINFORMTm

Abstract No. Impact of STK11 mutation on first-line immune checkpoint9106 inhibitor outcomes in a real-world KRAS G12C mutant lung adenocarcinoma cohort.

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 commercially launched liquid biopsy-based Guardant360(r), Guardant360 CDx, and GuardantOMNI(r) tests for advanced stage cancer patients, and Guardant Reveal(tm) test for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic 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, 2020 and in its other reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended March 31, 2021. 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.

References

* Kim ST, Raymond VM, Park JO, et al. Combined genomic and epigenomic assessment of cell-free circulating tumor DNA (ctDNA) improves assay sensitivity in early-stage colorectal cancer (CRC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 916. * Westesson O, Axelrod H, Dean J, et al. Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer (CRC). Poster presented at: The American Association for Clinical Research Virtual Annual Meeting II; June 22-24, 2020. * Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncology. 2019; 5 (8): 1125-1131. * Tie J, Wang Y, Tomasetti C, Li L, Springer S, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Science Translational Medicine. 2016; 8 (346): 346ra92. * Tie J, Cohen J, Wang Y, et al. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer. JAMA Oncology. 2019; 5(12): 1710-1717 * Peng J, Li Y, Mo S, Ma X, Hu X, Zhang L, et al. Prognostic value of circulating tumor DNA (ctDNA) detection during adjuvant chemotherapy in patients with stage III colorectal cancer: The interim report of a prospective, observational study. Journal of Clinical Oncology. 2020; 38, no.4_suppl. * Tarazona N, Gimeno-Valiente F, Gambardella V, et al. Targeted next-generation sequencing of circulating-tumor DNA for tracking minimal residual disease in localized colon cancer. Annals of Oncology. 2019; 30 (11): 1804-1812. * Reece M, Saluja H, Hollington P, Karapetis C, et al. The Use of Circulating Tumor DNA to Monitor and Predict Response to Treatment in Colorectal Cancer. Frontiers in Genetics. 2019; 10: 1118. * Parikh AR, Van Seventer EE, Siravegna G, Hartwig AV, et al Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients. Clinical Cancer Research. 2021 Apr 29. View source version on businesswire.com: https://www.businesswire.com/news/home/20210519005968/en/

CONTACT: Investor Contact: Carrie Mendivil investors@guardanthealth.com

CONTACT: Media Contact: Anna Czene press@guardanthealth.com Julie Johnson julie.johnson@uncappedcommunications.com