Guardant and NRG Oncology initiate NRG-GI005 study in colon cancer

Survival rate for stage II colon cancer is about 58 to 88% and patients will gain from additional treatments

Guardant Health, Inc., a renowned precision oncology firm, along with NRG Oncology, a National Clinical Trials Network group that conducts both translational and clinical research, have commenced the NRG-GI005 trial for clinical utility validation of the molecular residual disease (MRD) assay of Guardant Health as a diagnostic biomarker to select which patient suffering from stage II colon required an adjuvant chemotherapy.

Apparently, the Circulating TumOr DNA (ctDNA) as a Predictive Biomarker in Stage II Colon Cancer’s Adjuvant Chemotherapy, also called the NRG-GI005 COBRA study, is essentially a multi-center randomized trial that will be enrolling about 1,408 patients suffering from resected stage II colon cancer and will be able to meet the active surveillance as per the physician’s criteria. The patients shall be randomized to be either receiving standard of care active surveillance or therapy based on ctDNA.

Seemingly, the survival rate for stage II colon cancer is about 58 to 88% and indicates that patients will gain from additional treatments. 

The main endpoint of the study is to assess non recurrent survival in patients suffering from ctDNA post-operation as well as treated with chemotherapy in comparison with the existing standard-of-care surveillance. 

Principal Study Investigator and Assistant Professor at Anderson Cancer Center, Van Morris, MD, stated that there is a lack of tools that could predict the success or unsuccessful treatment of stage II colon cancer in patients by surgery alone. If the study proves to be successful, it will authenticate MRD’s clinical utility as a biomarker in identifying patients who can gain from the adjuvant chemotherapy.

Morris further added that the company is looking forward to working with Guardant Health as well as using the company’s LUNAR-1 assay for the given study. The company chose Guardant due to its performance of the assay that incorporates both the methylation profiling and gene mutations and has successfully secured an affirmative predictive value for 100 percent recurrence in recent study.

 

Source Credit- http://investors.guardanthealth.com/news-releases/news-release-details/guardant-health-and-nrg-oncology-initiate-randomized-trial