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Guardant Health and NRG Oncology Initiate Randomized Trial to Investigate Circulating Tumor DNA Guided Adjuvant Therapy in Stage II Colon Cancer

LUNAR-1 liquid biopsy assay will be used to identify molecular residual disease and support its validation as a diagnostic biomarker

REDWOOD CITY, Calif. and PITTSBURGH, Pa., Jan. 12, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (GH), a leading precision oncology company, and NRG Oncology, a National Cancer Institute (NCI) funded National Clinical Trials Network group conducting clinical and translational research, have initiated the NRG-GI005 study to validate the clinical utility of Guardant Health’s molecular residual disease (MRD) assay as a diagnostic biomarker for selecting which patients with stage II colon cancer need adjuvant chemotherapy.

The NRG-GI005 COBRA study, or Circulating TumOr DNA (ctDNA) as a Predictive BiomarkeR in Adjuvant Chemotherapy in Stage II Colon Cancer, is a prospective multi-center randomized controlled trial that will enroll 1,408 patients with resected stage II colon cancer who meet their physician’s criteria for active surveillance. Patients will be randomized to either receive ctDNA-directed therapy or standard of care active surveillance. The study’s primary endpoint is to evaluate recurrence-free survival in patients who are ctDNA-positive post-operatively and treated with chemotherapy as compared to the current standard-of-care active surveillance.

“Today we lack tools to predict which patients with stage II colon cancer have been successfully treated by surgery alone and which need further treatment.  If successful, this study will validate the clinical utility of MRD as a biomarker to identify those patients who will benefit from adjuvant chemotherapy,” said Van Morris, MD, Principal Study Investigator and Assistant Professor, MD Anderson Cancer Center.  “We look forward to working with Guardant Health and using their LUNAR-1 assay for this study. Given the importance of this work, we selected Guardant because of the performance of their assay, which incorporates somatic gene mutations and methylation profiling, and achieved a positive predictive value for recurrence of 100 percent in a recent study.”

“Because five-year survival rates for stage II colon cancer are relatively high, most of these patients are not offered adjuvant chemotherapy after surgery. We are eager to demonstrate the clinical utility of our LUNAR-1 blood test to help identify the subset of patients who may benefit from chemotherapy based on their MRD status post surgery,” said AmirAli Talasaz, PhD, Guardant Health President. “We look forward to partnering with NRG Oncology and the NCI to address this important unmet medical need. Ultimately, the best chance to successfully treat cancer is to detect and intervene appropriately when the disease is still in its earliest stages.”

The LUNAR-1 assay has been designed to overcome a variety of challenges that have confounded previous approaches for MRD detection in early-stage cancers, including biological noise and the limited sensitivity of genomic-only and protein-based tests. With a single blood draw, the assay is simultaneously able to detect tumor-specific genomic alterations and epigenomic signatures with high clinical sensitivity and specificity. Guardant developed the LUNAR-1 assay based on its extensive experience processing more than 100,000 liquid biopsies from patients with advanced cancer through Guardant360. Recent data showed the LUNAR-1 assay’s ability to identify MRD in early-stage colorectal cancer patients who may benefit from adjuvant therapy after undergoing a curative-intent intervention.1

Colorectal cancer is the second most common cause of cancer death in the United States. It is estimated that there are more than one million colorectal cancer survivors alive today, and each year 104,000 new cases of colon cancer are diagnosed.2 The 5-year survival rate for patients with stage II colon cancer ranges from 58 to 88 percent and while relatively high, suggests that many patients may benefit from additional treatment.3

NRG-GI005 COBRA can be found at clinicaltrials.gov: NCT04068103.

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 and GuardantOMNI tests for advanced stage cancer patients. In 2018, the company also launched the LUNAR assay for research use only, which is being used for applications related to guiding neoadjuvant or adjuvant decision-making and recurrence monitoring. In parallel, Guardant Health is actively exploring the performance of the LUNAR assay in initial studies related to screening and early detection in asymptomatic individuals.

www.guardanthealth.com

About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of people with cancer. As one of the five research groups in the National Cancer Institute (NCI) funded National Clinical Trials Network (NCTN), NRG Oncology carries out clinical trials on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites worldwide, primarily in the United States and Canada. NRG Oncology is a non-profit research organization, funded mainly through grants from the NCI.
www.nrgoncology.org

Guardant Health Forward Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the COBRA trial, which involve risks and uncertainties that could cause Guardant Health’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2018, and in its other reports filed by Guardant Health with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, 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.

In light of the foregoing, 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.

Guardant Health Investor Contact:
Carrie Mendivil
investors@guardanthealth.com

Guardant Health Media Contact:
Anna Czene or Ian Stone
press@guardanthealth.com

References:

  1. Parikh AR, Van Seventer EE, Boland GM, et al. A plasma-only integrated genomic and epigenomic circulating tumor DNA (ctDNA) assay to inform recurrence risk in colorectal cancer (CRC). Journal of Clinical Oncology 2019 37:15_suppl, 3602-3602
  2. https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html. Accessed online Jan.  10, 2020.
  3. Gunderson LL, Jessup JM, Sargent DJ, et al. Revised TN Categorization for Colon Cancer Based on National Survival Outcomes Data, Journal of Clinical Oncology 2010 28:2, 264-271