Innovative Colon Cancer Assay Study Launched
A leading precision oncology company and NRG Oncology announced they have initiated the NRG-GI005 study to validate the clinical utility of a 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.
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.
“Because 5-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, Ph.D., Guardant Health President, in a press release.
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.
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, said the company.
Colorectal cancer is the 2nd most common cause of cancer death in the United States. It is estimated that there are more than 1 million colorectal cancer survivors alive today, and each year 104,000 new cases of colon cancer are diagnosed, says the American Cancer Society.
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.
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through the use of its proprietary blood tests, vast data sets, and advanced analytics. www.guardanthealth.com
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of people with cancer.
Colorectal Cancer news published by Vax-Before-Cancer.