Friday, June 30, 2023
Merus N.V.an innovative clinical-stage oncology company specializing in full-length multispecific antibodies (Biclonics and Triclonics) for cancer treatment, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for their drug, zenocutuzumab (Zeno), intended to treat advanced unresectable or metastatic NRG1 fusion (NRG1+) pancreatic cancer. This designation is specifically for patients who have experienced disease progression after prior systemic therapy or have no satisfactory alternative treatment options. Zeno previously received Fast Track Designation for metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancer) in January 2021 and Orphan Drug Designation for pancreatic cancer treatment in July 2020.
The Breakthrough Therapy Designation is based on data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP), which evaluate Zeno's safety and anti-tumor activity in NRG1+ cancer. As of June 1, 2023, over 175 patients with NRG1+ cancer have been treated with Zeno monotherapy. The designation aims to expedite the drug's development and review process due to its potential to substantially improve clinically significant endpoints over existing therapies. It allows for more intensive guidance from the FDA, involving senior managers and experienced review staff in a collaborative review, as well as eligibility for rolling review and priority review. Merus plans to engage in these discussions with the FDA to potentially submit a Biologics License Application (BLA).
Merus believes that securing a commercialization partnership agreement will be crucial to bringing Zeno to patients with NRG1+ cancer, pending approval.
Bill Lundberg, M.D., President, and Chief Executive Officer of Merus, expressed confidence in Zeno's clinical data and the Breakthrough Therapy Designation, which offers the opportunity to accelerate the review process for a potential BLA submission. Additionally, Merus intends to partner with other organizations for Zeno as part of their strategy to balance value creation and capital allocation requirements across their portfolio.
In 2023, Merus plans to provide a clinical update on Zeno's progress in NRG1+ cancer at a major medical conference.
Furthermore, Merus is evaluating Zeno's use in combination with androgen deprivation therapy (enzalutamide or abiraterone) for castration-resistant prostate cancer (CRPC), regardless of NRG1+ status. Initial clinical data on Zeno's performance in CRPC is expected to be presented in the second half of 2023. Merus is also exploring Zeno's potential in combination with afatinib for patients with NRG1+ NSCLC.