REDWOOD CITY, Calif., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (GH), announces a strategic collaboration to develop and help support commercialization of a blood-based companion diagnostic (CDx) test for Amgen’s AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein, globally. Under the agreement, Guardant Health will pursue U.S. Food and Drug Administration (FDA) Pre-Market Approval, Japan Pharmaceutical and Medical Device Agency Approval, and European CE-Mark for Guardant360® CDx as a companion diagnostic for AMG 510 in metastatic non-small cell lung cancer (NSCLC) patients with the KRAS G12C mutation.
AMG 510 is the first-in-class KRAS G12C inhibitor to advance to the clinic, and Amgen is currently enrolling patients in a potentially registrational Phase 2 study. AMG 510 is designed to selectively and irreversibly target a specific mutant form of KRAS called G12C that is present in nearly 13 percent of all NSCLC patients1 and for whom limited targeted treatment options have existed to date. The FDA granted Orphan Drug Designation to AMG 510 for previously treated metastatic NSCLC and colorectal cancer with KRAS G12C mutation and Fast Track Designation for previously treated metastatic NSCLC with KRAS G12C mutation.
“In a recent head-to-head study of liquid versus tissue testing,2 Guardant demonstrated that advanced non-small cell lung cancer patients are not consistently receiving adequate genotyping results from tissue,” said AmirAli Talasaz, PhD, Guardant Health President. “We believe that the development of Guardant360 CDx will lead to consistently delivered guideline-complete genotyping results along with other important genomic information to patients and their providers through blood, which will ultimately increase the number of patients who are identified as eligible for targeted therapies, including AMG 510, and thus improve access to these potentially life-changing treatments.”
“The potential of AMG 510 to specifically target KRAS G12C, a mutation that was once thought to be undruggable, represents a major therapeutic advancement in advanced non-small cell lung cancer,” said Sanket Agrawal, general manager of the KRAS program at Amgen. “Amgen is committed to driving broad accessibility to biomarker testing. Collaborating with Guardant Health to develop their Guardant360 blood test as a companion diagnostic will help ensure that all eligible non-small cell lung cancer patients receive biomarker testing.”
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 and LUNAR assay for research use and for use in prospective clinical trials. 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.
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the adoption of Guardant Health’s products, 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.
- Lipford, JR. Pre-clinical development of AMG 510: the first inhibitor of KRASG12C in clinical testing. Oral presentation at AACR 2019, Atlanta, GA. March 29-April 3, 2019.
- Leighl NB, Page RD, Raymond VM, et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer, Clin Cancer Res. 2019 April.