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Foundation Medicine, Takeda Collaborate to Develop CDx for NSCLC Therapies

NEW YORK – Foundation Medicine announced Friday its collaboration with Takeda Pharmaceuticals USA to develop Foundation's companion diagnostics for use with Takeda's lung cancer portfolio.

Financial and other terms of the deal were not disclosed. 

Foundation's FoundationOne CDx and FoundationOne Liquid CDx would be used to identify patients eligible for mobocertinib or brigatinib (Takeda's Alunbrig). Mobocertinib is an investigational drug that is being evaluated for treatment of patients with epidermal growth factor receptor Exon20 insertion+ metastatic non-small cell lung cancer, and brigatinib is Takeda's tyrosine kinase inhibitor to treat patients with TKI-naïve anaplastic lymphoma kinase-positive mNSCLC. 

EGFR Exon20 insertion mutations occur in 1 to 2 percent of patients with mNSCLC, while ALK+ mNSCLC is found in approximately 3 to 5 percent of patients with mNSCLC, according to Foundation Medicine, a Roche subsidiary.

The collaboration "will address an urgent need for broad access to genomic tests, ultimately expanding treatment options and potentially improving outcomes for people with ALK+ and EGFR Exon20 insertion+ mNSCLC," Christopher Arendt, head of the oncology therapeutic area unit at Takeda, said in a statement.

FoundationOne Liquid CDx uses next-generation sequencing to analyze 324 genes and is approved by the US Food and Drug Administration to report short variants in 311 genes. FoundationOne CDx uses NGS to detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. It also detects genomic signatures, including microsatellite instability and tumor mutational burden.