Global Diagnostic Collaborations Announced by Amgen To Expand Molecular Testing For Patients With Non-Small Cell Lung Cancer

Amgen announced strategic collaborations with leading diagnostic companies Guardant Health, Inc. and QIAGEN N.V. to develop blood- and tissue-based companion diagnostics (CDx), respectively, for investigational cancer treatment AMG 510. AMG 510 is the first KRASG12C inhibitor to advance to the clinic for investigation in treatment of multiple tumor types. KRAS G12C is one of the most frequently mutated oncogenes in human cancers. The agreements with both companies will initially focus on CDx tests for non-small cell lung cancer (NSCLC) but allow for further development of the diagnostic tests for Amgen’s other oncology clinical development programs.

“Amgen is committed to driving broad accessibility to biomarker testing in order to select appropriate patients who will directly benefit from targeted treatments,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “With one in eight patients with NSCLC having KRAS G12C, there’s a critical need to improve access to high quality diagnostics and more routine screening. Collaborating with QIAGEN and Guardant Health to have both tissue- and blood-based diagnostic tests available will help to identify patients with NSCLC who may benefit from AMG 510.”

Amgen will work with QIAGEN to develop a tissue-based diagnostic test utilizing its therascreen® platform to identify patients whose cancers have the KRAS G12C mutation. QIAGEN will also pursue global regulatory approvals, including Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA). To enable biomarker testing in patients for whom insufficient tissue remains a challenge, Amgen is also collaborating with Guardant Health to develop a liquid biopsy CDx. Guardant360 CDx is a multi-tumor comprehensive NGS (Next Generation Sequencing) test that is being developed to identify patients with actionable alterations, in this instance with the KRAS G12C mutation in NSCLC. Guardant Health will seek global regulatory approvals for the test, including a PMA from the FDA.

AMG 510 is currently enrolling patients in a potentially registrational Phase 2 study (CodeBreak™ 100). 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.

Amgen established RAS as the first actionable biomarker in metastatic colorectal cancer and is now pioneering the development of KRAS mutation specific inhibitors in lung cancer and other solid tumors with AMG 510.

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