Foundation Medicine, Takeda to Work on NSCLC Companion Diagnostics

September 19, 2020

If approved, FoundationOne's CDx would be used to identify patients with non–small cell lung cancer (NSCLC) who are eligible for mobocertinib or brigatinib.

Foundation Medicine and Takeda Pharmaceuticals said Friday they will collaborate on development of Foundation’s tissue- and blood-based companion diagnostics for use with Takeda’s late-stage lung cancer portfolio.

If approved, FoundationOne CDx and FoundationOne Liquid CDx would be used to identify patients eligible for mobocertinib or brigatinib.

Last April, the FDA granted a breakthrough therapy designation to mobocertinib (TAK-788) for the treatment of patients with EGFR exon 20–mutant non–small cell lung cancer (NSCLC) with metastatic disease after platinum-based chemotherapy.

Brigatinib, Takeda's tyrosine kinase inhibitor (TKI) sold as Alunbrig to treat patients with TKI-naïve anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC, was approved in May.

NSCLC is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new patients diagnosed each year worldwide, and 40% of patients develop metastatic disease.

EGFR exon 20 insertion mutations happen in about 1% to 2% of patients with mNSCLC and there are no FDA-approved targeted treatment options.

ALK+ mNSCLC is a complex and aggressive form of lung cancer found in approximately 3% to 5% of patients with mNSCLC.

“Our collaboration with Foundation Medicine 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 Takeda’s Oncology Therapeutic Area Unit, said in a statement. “Robust, accurate and timely testing is crucial to enable oncologists to make informed treatment decisions so that advanced cancer patients receive the optimal therapy for their disease.”

FoundationOne Liquid CDx uses next-generation sequencing (NGS) to analyze 324 genes and 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.