Roche subsidiary Foundation Medicine has announced a collaboration with Merus to advance its RNA platform as a companion diagnostic for Merus' bispecific antibody, Zeno (zenocutuzumab), aimed at treating patients with neuregulin 1 (NRG1) fusion-positive cancer. Zeno targets the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions.
The U.S. Food and Drug Administration (FDA) has accepted a biologics license application for Zeno under priority review for patients with NRG1 fusion-positive non-small cell lung cancer (NSCLC) and pancreatic cancer. Additionally, Zeno has been granted breakthrough therapy designation for advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer, especially in cases where patients have progressed after prior systemic therapy or lack alternative treatment options. The drug also received breakthrough therapy designation for treating advanced unresectable or metastatic NRG1 fusion-positive NSCLC following the progression of prior systemic treatments.
FoundationOne RNA, Foundation Medicine's RNA sequencing platform, plays a critical role in this partnership. The platform detects fusions in 318 genes and provides gene expression data for over 1,500 genes from tissue samples.
Troy Schurr, Foundation Medicine's Chief Biopharma Business Officer, expressed enthusiasm about the partnership, stating, "We are excited to partner with Merus on this RNA companion diagnostic opportunity to provide fusion detection through next-generation sequencing. 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."