Merus N.V., a pioneering oncology company specializing in innovative antibodies for cancer treatment, has recently announced a significant breakthrough in therapy. The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Merus' zenocutuzumab (Zeno) for the treatment of advanced unresectable or metastatic NRG1 fusion (NRG1+) non-small cell lung cancer (NSCLC) patients who have experienced progression after prior systemic therapy. This latest BTD follows Merus' previous designation for the treatment of NRG1+ pancreatic cancer. The recognition of Zeno's potential to provide substantial improvements in patients' lives reflects its efficacy and positions it as a leading targeted agent for NRG1+ cancer.

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Promising Data from Ongoing Trials

Merus' BTD is supported by compelling data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP). These initiatives are evaluating the safety and anti-tumor activity of Zeno as a monotherapy in NRG1+ cancer. Notably, the findings from the eNRGy trial and EAP were presented as oral presentations during the 2021 and 2022 American Society of Clinical Oncology Annual Meetings, highlighting the significant progress achieved. To date, Zeno monotherapy has been administered to over 175 patients with NRG1+ cancer, further solidifying its potential as an effective treatment option.

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Breakthrough Therapy Designation and its Benefits

Breakthrough Therapy Designation is a valuable designation granted by the FDA to expedite the development and review of medicines for serious or life-threatening conditions. The designation is awarded when preliminary clinical evidence suggests that the drug can offer substantial improvement over available therapies in terms of clinically significant endpoints. BTD enables more rigorous FDA guidance and collaboration, involving senior managers and experienced review staff, to facilitate an efficient drug development program. Furthermore, it allows for rolling review and priority review, potentially accelerating the approval process. Merus is eager to engage in these discussions with the FDA promptly and will provide updates on the path and timeline to a potential Biologics License Application (BLA) submission.

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Future Plans and Commercialization Partnership

Merus is optimistic about the prospect of a commercialization partnership agreement to bring Zeno to patients with NRG1+ cancer following its potential approval. The company recognizes the importance of collaborating with a commercial partner to ensure widespread availability and accessibility of this targeted agent. Merus intends to share a clinical update on Zeno in NRG1+ cancer at a major medical conference scheduled for 2023, underscoring its commitment to transparency and communication within the medical community.

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Exploring Combination Therapies

In addition to its focus on monotherapy, Merus is actively evaluating Zeno in combination with androgen deprivation therapy (enzalutamide or abiraterone) for castration-resistant prostate cancer (CRPC), regardless of NRG1+ status. The company plans to present initial clinical data on Zeno in CRPC during the second half of 2023. Merus is also conducting studies on Zeno in combination with afatinib for patients with NRG1+ NSCLC, expanding its potential application and impact in the field of oncology.