As ESMO 2023 kicks off, the pharmaceutical companies, including Daiichi Sankyo, Bristol Myers Squibb, AstraZeneca, Merus, Merck, and more, are on the edge of their seats, eager to showcase their groundbreaking NSCLC research in both oral and poster presentations. Merus' zenocutuzumab, is all set to provide a glimpse from its  eNRGy clinical study.

• Abstract Number – #1315MO
• Abstract Type – Mini Oral Session
• Indication – NSCLC
• Target – NRG Fusion-positive NSCLC

Merus' Zenocutuzumab demonstrates potent, durable efficacy in NRG1+ cancers, with a unique mechanism targeting the neuregulin/HER3 pathway. Anticipated BLA submissions for NRG1+ NSCLC and PDAC expected by H1 2024.

Merus is currently enrolling patients in the phase I/II eNRGy trial to assess the safety and anti-tumor activity of zenocutuzumab monotherapy in NRG1+ cancer. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and other NRG1+ cancer.

Zenocutuzumab is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, zenocutuzumab has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, the drug inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation, and blocking tumor cell survival.

According to the company, the drug continues to show remarkably consistent efficacy over time, with robust and durable responses in these difficult-to-treat indications. The drug has received two breakthrough therapy designations by the US FDA and it is expected that the company will have sufficient data for both NRG1+ NSCLC and NRG1+ PDAC in the first half of 2024 to support biologics license application submissions.

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.