Zenocutuzumab (Zeno) granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for the treatment of NRG1+ pancreatic cancer

Excerpt from the Press Release:

UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 29, 2023 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics^® and Triclonics^®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. This designation for Zeno follows a Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancer) that have progressed on standard of care therapy on January 7, 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer on July 27, 2020.

BTD is supported by data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP) which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer (Phase 1/2: NCT02912949, EAP: NCT04100694). Data from the eNRGy trial and EAP were featured as oral presentations during the 2021 and 2022 American Society of Clinical Oncology Annual Meetings (Abstract #3003, #105 respectively). As of June 1, 2023, more than 175 patients with NRG1+ cancer have been treated with Zeno monotherapy.

BTD is intended to expedite the development and review of a medicine to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints over available therapies.

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