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™ 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 comparable sensitivity to tissue-dependent
approaches (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® 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™ 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 KRAS G12C 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® 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. 3536
Multimodal circulating tumor DNA
(ctDNA) colorectal neoplasia detection assay for asymptomatic and
early-stage colorectal cancer (CRC)
Guardant Reveal™
Abstract No. 3045
Multiomic, plasma-only ctDNA NGS
assay for minimal residual disease (MRD) detection in solid
tumors.
Abstract No. 3565
Circulating tumor derived
cell-free DNA (ctDNA) to predict recurrence of metastatic
colorectal cancer (mCRC) following curative intent surgery or
radiation.
Abstract No. TPS3622,
TPS148
Phase II/III study of circulating
tumor DNA as a predictive biomarker in adjuvant chemotherapy in
patients with stage II colon cancer: NRG-G1005 (COBRA).
Guardant 360®
Abstract No. 3040
Blood-based tumor mutational
burden from circulating tumor DNA (ctDNA) across advanced solid
malignancies using a commercially available liquid biopsy
assay.
Abstract No. 9027
Clinical outcomes for
plasma-based comprehensive genomic profiling versus tissue testing
in advanced lung adenocarcinoma.
Abstract No. 4130
Circulating cell free tumor DNA
detection as a prognostic tool in advanced pancreatic cancer.
Abstract No. 9011
Early circulating tumor DNA
dynamics and efficacy of lorlatinib: Analysis from the CROWN
study.
Abstract No. 1028
Identification of pathogenic
CDK12 alterations in cell-free DNA (cfDNA) from patients with
breast cancer.
Abstract No. 8577
Cell-free circulating tumor DNA
(cfDNA) analysis of advanced thymic epithelial tumors (TETs).
Abstract No. 4585
Circulating tumor DNA (ctDNA) in
patients with advanced adrenocortical carcinoma.
Abstract No. 9108
Genomic landscape differences in
patients with advanced non-small cell lung cancer by sex and
age.
Abstract No. 3523
Circulating tumor DNA-based
genomic profiling of small bowel
adenocarcinoma.
Abstract No. e17018
Serial ctDNA profiling in
patients with metastatic prostate cancer undergoing treatment with
Radium-223.
Abstract No.
3572
Serial circulating tumor DNA
(ctDNA) monitoring in metastatic colorectal cancer (mCRC) reveals
dynamic profile of actionable alterations.
Abstract No. 5038
Complementary detection of
genomic alterations in metastatic castration‑resistant prostate
cancer (mCRPC) from CheckMate 9KD through analyses of tumor tissue
and plasma DNA.
Abstract No. 3589
Assessment of HER2 (ERBB2)
amplification (HER2amp) using blood-based circulating tumor DNA
(ctDNA) next generation sequencing (NGS) and correlation with
tissue-based testing in metastatic colorectal cancer (mCRC)
Abstract No. 4058
Early predictors of benefit to
dual anti-PD1/HER2 inhibition: Biomarker analysis from phase 2
trial of pembrolizumab/trastuzumab in HER2-positive metastatic
esophagogastric (mEG) cancer.
Abstract No. 3555
Pertuzumab plus trastuzumab and
real-world standard of care (SOC) for patients (pts) with treatment
refractory metastatic colorectal cancer (mCRC) with HER2 (ERBB2)
amplification (amp) confirmed by tumor tissue or ctDNA
analysis.
GuardantINFORM™
Abstract No. 9106
Impact of STK11 mutation on
first-line immune checkpoint 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®,
Guardant360 CDx, and GuardantOMNI® tests for advanced stage cancer
patients, and Guardant Reveal™ 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.
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Investor Contact: Carrie Mendivil
investors@guardanthealth.com
Media Contact: Anna Czene press@guardanthealth.com Julie
Johnson julie.johnson@uncappedcommunications.com
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