SLLIP Study Meets Primary Endpoint, Finds the Guardant360 Assay Performs Similar to Standard-of-Care Tissue Testing in Advanced NSCLC, Investigators to Report at WCLC

Guardant360 Could Save More Than $10,000 per Patient, Separate Abstract Shows

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Sep 05, 2018, 19:22 ET

REDWOOD CITY, Calif., Sept. 5, 2018 /PRNewswire/ -- Researchers will present data at the 19^th World Conference on Lung Cancer (WCLC) showing the SLLIP trial met its primary endpoint of demonstrating that the blood-based Guardant360^® assay detected genomic alterations that affect treatment selection in first-line, advanced NSCLC at a similar rate (non-inferiority) to standard-of-care tissue testing.

The MedSIR-sponsored SLLIP trial (Spanish Lung Liquid versus Invasive biopsy Program) prospectively enrolled 185 patients with metastatic non-small cell lung cancer. Each patient was tested with Guardant360 as well as standard-of-care tissue molecular testing ahead of first-line treatment.

Throughout the entire cohort, Guardant360 identified a similar number of targets associated with guideline-recommended treatment as tissue did, with Guardant360 finding 47 and tissue finding 48, investigators reported. A final analysis on the treatment plans and outcomes for these patients will occur by mid 2019.

In a separate poster session, researchers will describe a cost-benefit model to estimate the savings that comprehensive genomic testing with the Guardant360 in advanced NSCLC could provide a typical health plan with 10 million lives covered. They found Guardant360 testing could save more than $10,000 per patient when used before first-line treatment and more than $13,000 when it is used to look for a new target when a patient is progressing on an ongoing line of treatment. The majority of the savings result from identifying patients who are not likely to respond to immunotherapy and immunotherapy-based combinations, so they can avoid the expense and adverse events associated with those treatments.

"Taken together, we believe these two studies, along with 10 others to be presented at WCLC, show the value Guardant360 can provide in the management of advanced NSCLC before first-line therapy," said Guardant Health Chief Medical Officer Richard Lanman, MD. "These results should increase confidence in the use of Guardant360 in newly-diagnosed patients with advanced NSCLC."

The SLLIP study is the first of two prospective trials comparing the detection rates of Guardant360 to standard-of-care tissue-based genomic testing in untreated advanced NSCLC. The NILE study (Noninvasive vs. Invasive Lung Evaluation), a larger Guardant Health-sponsored trial, is underway across multiple sites in North America. An interim analysis of those results is expected to be presented in the first half of 2019.

Since its introduction in 2014, the Guardant360 assay has been ordered more than 70,000 times to help inform which therapy may be effective for advanced stage cancer patients with solid tumors. It has been reviewed by more than 80 peer-reviewed publications, which address its analytical validity, clinical validity, and clinical utility. Guardant360 is covered Medicare and by several private payers, including Cigna and several Blue Cross Blue Shield plans.

About Guardant Health, Inc.

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. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer, which fuel its development programs for recurrence and early detection, LUNAR-1 and LUNAR-2, respectively. Since its launch in 2014, Guardant360 has become the world's market-leading comprehensive liquid biopsy test and has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 National Comprehensive Cancer Network centers. Learn more at www.guardanthealth.com.

SOURCE Guardant Health