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Guardant Health, Daiichi Sankyo to Develop CDx for HER-2 NSCLC Drug

NEW YORK – Guardant Health said Tuesday that it has entered a strategic collaboration with Daiichi Sankyo to pursue regulatory approval of its Guardant360 CDx assay as a companion diagnostic for the pharma firm's HER-2 antibody-drug conjugate, fam-trastuzumab deruxtecan-nxki (Enhertu), for the treatment of patients with advanced metastatic non-small cell lung cancer.

Financial terms of the agreement were not disclosed.

Guardant360 CDx is already approved by the US Food and Drug Administration to provide comprehensive genomic profiling to guide treatment in all solid tumors, including NSCLC. It also has specific companion diagnostic approval to identify non-small cell lung cancer patients who may benefit from treatment with osimertinib (AstraZeneca's Tagrisso).

In a statement, Guardant CEO Helmy Eltoukhy said that the emergence of molecularly targeted cancer drugs, as well as tests like Guardant360 that identify the patients eligible for them, has already been "life-changing" for NSCLC patients with NSCLC, but therapies like Daiichi Sankyo's can address "an unmet medical need to help non-small cell lung cancer patients with HER2 mutations."