Guardant Health says a clinical study has generated positive results showing that its Guardant360 assay was comparable to standard-of-care tissue testing for identifying National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first-line advanced non-small cell lung cancer (NSCLC) patients.
The Noninvasive vs. Invasive Lung Evaluation (NILE) study (NCT03615443) showed that Guardant360 detected targetable genomic biomarkers at a similar rate to tissue, thus meeting its primary endpoint.
“This is an important new dataset for clinical oncologists that we believe will further accelerate adoption of Guardant360 and, taken together with other recent independent investigations into Guardant360 in this clinical setting, solidifies the case for using blood first for treatment selection,” Guardant Health CEO Helmy Eltoukhy, PhD, said in a statement.
NILE is a prospective, multi-center study of 282 newly diagnosed, advanced NSCLC patients. Each patient was tested with Guardant360 and the physician’s choice of tissue-based testing. Results of the tests were compared for the detection of the NCCN-recommended biomarkers important for treatment selection: EGFR, ALK, BRAF, RET, ROS1, MET, and ERBB2.
Investigators found that Guardant360 identified guideline recommended-biomarkers in 77 patients; tissue testing identified them in 60. Tissue testing also detected the same alteration as seen in each patient in whom Guardant360 identified a target of an FDA-approved drug (EGFR, ALK, BRAF, ROS1).
The median time to results for Guardant360 was an average of nine days, compared with 15 days for tissue testing. According to Guardant Health, the results of NILE support the use of blood-based biomarker testing ahead of tissue-based testing for all newly diagnosed advanced NSCLC patients.
“Given that this assay finds mutations at a similar rate to tissue-based testing, while ensuring patients receive guideline-complete testing with a faster turn-around time, it’s a compelling option to use liquid first ahead of tissue for molecular testing in newly diagnosed advanced NSCLC,” concluded Vassiliki Papadimitrakopoulou, MD, the NILE study’s senior author and chief section of thoracic medical oncology, MD Anderson Cancer Center.
Papadimitrakopoulou is scheduled to present results from NILE on April 2 at the American Association for Cancer Research (AACR) Annual Meeting 2019, set for March 29–April 3 in Atlanta.
Launched in 2014, Guardant360 is designed to measure 73 cancer-related genes from circulating tumor DNA (ctDNA). Guardant360 has been used by more than 6000 oncologists, over 50 biopharmaceutical companies and all 27 NCCN centers.