Abstract
One for liquid biopsies, another for tissue biopsies. That's the tack Pharma giant Amgen is taking with its announcements of partnerships with Guardant Health and Qiagen related to developing a liquid biopsy companion diagnostic (CDx) and a tissue based CDx, respectively, for its investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation.
The deals with each partner will initially focus on the KRAS G12C mutation as found in non-small cell lung cancer (NSCLC) which accounts for approximately 13% of all NSCLC cases. Development efforts for Guardant will leverage the company's Guardant360 CDx as a blood-based test, while Qiagen will apply its therascreen test to develop a tissue-based CDx.
Securing the CDx partners is an important first step to moving AMG 510 down the path to an approved drug. Amgen is currently enrolling patients in what could be a registrational Phase II study and the FDA has also granted Orphan Drug Designation to AMG 510 for previously treated metastatic NSCLC and colorectal cancer with KRAS G12C mutation as well as a Fast Track Designation for previously treated metastatic NSCLC with KRAS G12C mutation.
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