NEW YORK – Roche subsidiary Foundation Medicine said Wednesday that it will collaborate with Merus to develop its RNA platform as a companion diagnostic for the Dutch pharmaceutical firm's bispecific antibody Zeno (zenocutuzumab) to treat patients with neuregulin 1 fusion-positive cancer.
The drug inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions, Foundation said in a statement. The US Food and Drug Administration accepted a biologics license application for Zeno under priority review for patients with NRG1 fusion-positive non-small cell lung cancer and pancreatic cancer in May. The agency also granted breakthrough therapy designation for the treatment of patients with advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer after progression with prior systemic therapy or those with no alternative treatment options.
Zeno also received breakthrough therapy designation for the treatment of patients with advanced unresectable or metastatic NRG1 fusion-positive non-small cell lung cancer after progression with prior systemic therapy, Foundation said.
FoundationOne RNA uses RNA sequencing to detect fusions in 318 genes and offers gene expression reporting of more than 1,500 genes from tissue.
"We are excited to partner with Merus on this RNA companion diagnostic opportunity to provide fusion detection through next-generation sequencing," Troy Schurr, Foundation's chief biopharma business officer, said in a statement. "We anticipate this innovative molecular information will help detect more NRG1 fusions and provide healthcare providers with important information to inform their care decisions for patients."