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Guardant Health to Develop Liquid Biopsy CDx for Amgen KRAS G12C Inhibitor

NEW YORK — Guardant Health said on Monday that it is collaborating with Amgen to develop and commercialize a global blood-based companion diagnostic test for the pharmaceutical firm's investigational oral therapy AMG 510, which inhibits KRAS G12C mutant protein.

Under the terms of the agreement, Guardant will pursue approval of its Guardant360 CDx assay as a companion diagnostic to AMG 510 in metastatic non-small cell lung cancer patients with the KRAS G12C mutation. This will include seeking pre-market approval for the Guardant360 CDx assay from the US Food and Drug Administration as well as approval from the Japan Pharmaceutical and Medical Device Agency and a CE mark in Europe.

Amgen is currently enrolling patients in a registrational Phase II study of the KRAS G12 inhibitor, the first of its class to advance to the clinic. The drug is designed to selectively and irreversibly target KRAS G12C mutations, which the companies said are present in nearly 13 percent of all NSCLC patients. The FDA has previously granted orphan drug designation to the therapy for previously treated metastatic NSCLC and colorectal cancer patients with the KRAS G12C mutation, as well as fast track designation for previously treated metastatic NSCLC patients with the KRAS G12C mutation.

Sanket Agrawal, general manager of the KRASprogram at Amgen, said in a statement that the KRAS G12C variant was once thought to be undruggable, making the advancement of AMG 510 an exciting one for the oncology community.

Announcing the deal, Guardant also highlighted data it has been gathering that support the value of blood-based tests like its own, especially in areas where substantial proportions of patients are failing to be genotyped and a noninvasive option might help more patients realize the promise of precision oncology.

"In a recent head-to-head study of liquid versus tissue testing, Guardant demonstrated that advanced non-small cell lung cancer patients are not consistently receiving adequate genotypingresults from tissue," Guardant Health President AmirAli Talasaz said in a statement.

"We believe that the development of Guardant360 CDx will lead to consistently delivered guideline-complete genotyping results ... which will ultimately increase the number of patients who are identified as eligible for targeted therapies, including AMG 510," he added.

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