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

Rhea-AI Summary

Guardant Health (Nasdaq: GH) presented data at the 2021 ASCO Annual Meeting showcasing advancements in precision oncology through its blood tests. With 20 abstracts, the data emphasized the efficacy of blood-based genomic profiling in early-stage cancer screening and treatment monitoring. Key findings included a 91% sensitivity for early-stage colorectal cancer detection via the LUNAR-2 test and high predictive value of the Guardant Reveal test in detecting minimal residual disease. These innovations aim to enhance treatment decisions and patient outcomes in cancer care.

Positive

• LUNAR-2 test achieved 91% sensitivity and 94% specificity for early-stage colorectal cancer detection.
• Guardant Reveal test shows high predictive value for cancer recurrence with a median lead time of six months.
• Industry-leading 91% sensitivity in detecting ctDNA, enhancing early recurrence detection and treatment monitoring.

Negative

• None.

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 re

FAQ

What were the key findings from Guardant Health's presentation at ASCO 2021?

Guardant Health presented data on the effectiveness of their LUNAR-2 blood test with 91% sensitivity for early-stage colorectal cancer and the Guardant Reveal test's high predictive value for cancer recurrence.

What is the significance of the LUNAR-2 test's sensitivity in colorectal cancer?

The LUNAR-2 test's 91% sensitivity indicates its reliability in detecting early-stage colorectal cancer, making it a valuable tool for screening.

When was the 2021 ASCO Annual Meeting held?

The 2021 ASCO Annual Meeting took place from June 4 to June 8, 2021.

What does Guardant Reveal test for in cancer patients?

Guardant Reveal detects circulating tumor DNA (ctDNA) in patients with early-stage cancers and predicts recurrence in post-surgical settings.

How does Guardant Health contribute to precision oncology?

Guardant Health advances precision oncology through proprietary blood tests that enhance cancer screening, treatment selection, and monitoring.