On May 19, 2021 Guardant Health, Inc. (Nasdaq: GH), reported 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 (Press release, Guardant Health, MAY 19, 2021, View Source;and-Late-Stage-Cancers [SID1234580319]). 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) (Free ASCO Whitepaper) Annual Meeting being held from June 4-8, 2021.
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"The data at ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper)
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.