NILE Study Results Demonstrating Guardant360’s High Concordance to Tissue Testing in Advanced NSCLC Published in Clinical Cancer Research
Beyond meeting its primary endpoint of demonstrating that Guardant360 is as effective as standard-of-care tissue testing for the detection of guideline-recommended biomarkers in advanced NSCLC, investigators reported that using Guardant360 resulted in guideline- recommended testing for three times as many patients as standard-of-care tissue testing. Moreover, when results for Guardant360 and tissue testing were both available for a given patient, they were concordant in more than 90% of cases. Additionally, the median time to results for Guardant360 was 9 days versus 15 days for tissue testing. The study also showed that for EGFR L858R mutations, Guardant360’s clinical sensitivity was 90%.
“Not only do these results suggest that Guardant360 should be the first choice for obtaining genomic results for patients with advanced NSCLC, they demonstrate that standard-of-care tissue testing is failing to adequately genotype the vast majority of patients,” said
The NILE, or “Noninvasive versus Invasive Lung Evaluation” study 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 guideline-recommended biomarkers important for treatment selection in EGFR, ALK, BRAF, RET, ROS1, MET, and ERBB2. Knowing the status of these guideline-recommended biomarkers is important before beginning treatment for several reasons. Up to 30 percent of patients can be treated with targeted therapies that often have higher response rates than chemotherapy or immunotherapy. Moreover, patients who are eligible for these targeted drugs but are instead treated with immunotherapy may have worse outcomes.
Since its introduction in 2014, Guardant360 has been ordered by more than 6,000 oncologists for more than 100,000 patients with advanced cancer to help select treatment. The best-in-class performance of the assay is evidenced by more than 100 peer-reviewed publications, which address its analytical validity, clinical validity, and clinical utility in multiple tumor types.
This press release contains forward-looking statements within the meaning of federal securities laws, such as statements about the expected impact of the NILE study data. Such statements reflect Guardant Health’s current expectations, forecasts and assumptions. Actual results may vary materially from forward-looking statements due to risks, uncertainties and other factors, known and unknown to
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2 Aggarwal C, Thompson JC, Black TA, et al. Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non–Small Cell Lung Cancer. JAMA Oncol. 2019;5(2):173–180. doi:10.1001/jamaoncol.2018.4305
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Source: Guardant Health, Inc.