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Foundation Medicine, Relay Therapeutics to Develop FoundationOne CDx for FGFR2 Inhibitor

NEW YORK – Roche's Foundation Medicine announced on Monday that it will collaborate with Relay Therapeutics to develop FoundationOne CDx as a companion diagnostic for Relay's RLY-4008, an investigational FGFR2 inhibitor.

The drug is currently being evaluated for use in patients with FGFR2-mutated cholangiocarcinoma, or bile duct cancer, and other solid tumors, the companies said in a statement. If the therapy and FoundationOne CDx as a companion diagnostic are approved, the test would be used to identify patients with FGFR2 fusions and select rearrangements in cholangiocarcinoma who may be appropriate for treatment with the drug.

FGFR2 is a receptor tyrosine kinase that is often altered in certain cancers, and RLY-4008 is currently being evaluated in a clinical trial in patients with advanced or metastatic FGFR2-altered solid tumors, the companies said.

"FGFR2-mutated cholangiocarcinoma is an aggressive condition that's generally diagnosed in advanced stages when prognosis is poor and treatment options are limited," Don Bergstrom, president of R&D at Relay Therapeutics, said in a statement. "We're proud to partner with the leader in companion diagnostic approvals as we work to advance this potentially life-changing therapy and create access to it once approved."

Next-generation sequencing-based FoundationOne CDx is used as a companion diagnostic for a variety of drugs and detects substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, along with genomic signatures such as microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens.