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Large-Scale Study Shows Guardant360 Liquid Biopsy Accelerates Clinical Trial Enrollment Compared to Tissue Biopsy

October 5, 2020 Off By BusinessWire

Nature Medicine Publication Reports that Liquid Biopsy More Than Doubles Clinical Trial Enrollment Rate Compared to Tissue Biopsy

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH). Despite advances in precision oncology, progress is slowed by the limitations of tissue genotyping, which is traditionally used to enroll patients in clinical trials. A new study published in Nature Medicine,¹ led by the National Cancer Center Hospital East (NCCHE) in Japan, demonstrates that the Guardant360^® liquid biopsy is not only concordant to tissue genotyping, but also accelerates clinical trial enrollment, detects more actionable alterations, and achieves similar treatment response rates and progression-free survival in patients with advanced gastrointestinal cancer. Publication link here.

The study, SCRUM-Japan GOZILA, compares comprehensive genomic profiling using the Guardant360 liquid biopsy, versus tissue genotyping for trial enrollment into the SCRUM-Japan study network. Patients with advanced gastrointestinal cancer, including gastric and colorectal cancer, were matched to novel therapies that target the specific biomarkers identified. Compared to tissue genotyping (n=5,621) used in GI-SCREEN, the Guardant360 liquid biopsy (n=1,687) shortened screening duration by 67 percent (median 11 vs. 33 days) and improved trial enrollment rate by 132 percent (9.5 vs. 4.1 percent).

Additionally, the Guardant360 liquid biopsy revealed more actionable alterations because of its high success rate and ability to detect heterogeneously-distributed mutations which are often missed by single-locus tissue analysis. Most importantly, similar objective response rates and progression-free survival were seen in both studies, which included patients who were matched to interventional biomarker-targeted therapies when their cancer had progressed, after receiving first-line treatment.

“The data demonstrate that genomic profiling by ctDNA (circulating tumor DNA) analysis using the Guardant360 liquid biopsy has the advantage of shorter turnaround times and improved patient enrollment compared to tissue biopsy for clinical trials, without compromising treatment efficacy. (Read more…) The paradigm of precision oncology should be shifted toward greater use of liquid biopsies.” said the Principal Investigator of this study Dr. Yoshiaki Nakamura, Attending Physician, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East.

AmirAli Talasaz, Ph.D., Guardant Health President added, “These data complement other studies supporting the routine use of the Guardant360 test in personalized treatment decisions for patients with advanced cancer, and its potential to significantly accelerate the development and delivery of innovation in precision medicine to patients.”

The Guardant360 test is increasingly being used by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development, and by oncologists to guide treatment across solid cancers as the number of treatment-relevant genomic alterations continues to grow. Using next-generation sequencing, the Guardant360 test analyzes 74 genes using cell-free tumor DNA from blood samples and is broadly covered by Medicare for use across the vast majority of advanced solid tumors and many private payers. The Guardant360 CDx was recently approved by the FDA for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso^® (osimertinib).

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 launched liquid biopsy-based Guardant360^®, Guardant360 CDx, and GuardantOMNI^® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

About Guardant Health AMEA

Guardant Health AMEA (Asia, Middle East and Africa) is a joint venture between Softbank and Guardant Health, Inc. Guardant Health AMEA was formed to address the growing cancer burden in Asia, Middle East, and Africa.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential benefits and advantages of the Guardant360 liquid biopsy, 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. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in its other reports filed with the Securities and Exchange Commission. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, 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. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

References

Nakamura, Y., Taniguchi, H., Ikeda, M. et al. Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies. Nat Medicine (2020). https://doi.org/10.1038/s41591-020-1063-5