Press Release

Lung Cancer Study Published in JAMA Oncology Shows Guardant360 Outperforms Tissue Biopsy Alone in Identification of Targetable Mutations

October 16, 2018 at 8:00 AM EDT
Authors and accompanying editorial conclude study supports potential utilization of blood based genotyping ahead of tissue-based genotyping for advanced NSCLC patients

REDWOOD CITY, Calif., Oct. 16, 2018 /PRNewswire/ -- A prospective study in patients with advanced non-small cell lung cancer (NSCLC) has demonstrated that the blood based Guardant360® assay, developed by Guardant Health (Nasdaq:GH) identified clinically actionable mutations in nearly twice as many patients as tissue biopsy alone. Additionally, the results suggest a potential clinical strategy for treatment-naïve advanced NSCLC of plasma genotyping first ahead of traditional tissue genotyping.

Researchers from the Abramson Cancer Center of the University of Pennsylvania published the findings of the 323-patient study in JAMA Oncology, concluding that the results support routine use of a liquid biopsy blood test to guide treatment of patients with advanced NSCLC. An accompanying editorial, authored by oncologists from Harvard Medical School and Swedish Cancer Institute, stated "These results, combined with the patient satisfaction with the relative ease of providing blood rather than a solid tissue sample, suggest a clinical strategy of pursuing plasma NGS first, then tissue NGS if plasma NGS cannot detect relevant mutations."

"This landmark study is the first to show that a comprehensive and highly sensitive blood test, Guardant360, almost doubled the number of targetable mutations found with tissue genotyping alone, and should be used before the start of treatment so that all seven guideline-recommended genomic targets can be rapidly assessed," said Rick Lanman, MD, Guardant Health's Chief Medical Officer.

In one of the largest studies of its kind, oncologists used the Guardant360 test to evaluate 323 patients for clinically actionable mutations that guide initial and subsequent treatment decisions – either in combination with tissue biopsy or alone for 101 patients who were unable to undergo a tissue biopsy or for whom a tissue biopsy produced incomplete results. In all, among 229 patients that had concurrent plasma and tissue next generation sequencing (NGS) or were unable to complete tissue testing, Guardant360 found targetable mutations in nearly twice as many patients as the tissue biopsy alone, producing insights that guided standard of care treatment for 82 patients (36 percent) compared with 47 patients (20.5 percent).

Of the patients with targetable mutations identified, 67 were treated with a corresponding targeted therapy, with 42 patients being evaluated for response. Of those 42 patients, 37 demonstrated either a complete response, partial response or stable disease at the time of evaluation.

"The benefit seen in this study, especially among treatment-naïve patients, is extremely encouraging," noted Helmy Eltoukhy, PhD co-founder and CEO of Guardant Health. "Patients with lung cancer have access to a growing number of efficacious and well tolerated targeted therapies, and oncologists can use Guardant360 to find more actionable results faster, even before an invasive tissue biopsy has been performed."

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 in multiple tumor types. For advanced NSCLC, Guardant360 is covered by Medicare and by several private payers, including Cigna and several Blue Cross Blue Shield plans.

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.  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 patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

 

 

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