Zenocutuzumab is under clinical development by Merus and currently in Phase II for Metastatic Breast Cancer. According to GlobalData, Phase II drugs for Metastatic Breast Cancer have a 32% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Zenocutuzumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Zenocutuzumab overview

Zenocutuzumab (MCLA-128) is under development for the treatment of solid tumors that harbor Neuregulin 1 (NRG1) gene fusions, HER2 low expressing and HER2 positive metastatic breast cancer, pancreatic ductal adenocarcinoma , non-small cell lung cancer, Cholangiocarcinoma, metastati castration resistant prostate cancer and other solid tumors. It is administered by intravenous route as an infusion. The therapeutic candidate is a full-length IgG bi-specific antibody that acts by targeting HER2 and HER3. It is an antibody-dependent cellular cytotoxicity (ADCC)-enhanced Biclonic, that is developed based on Biclonics ENGAGE platform.

It was also under development for the treatment of ovarian cancer, metastatic colorectal cancer, epithelial tumor, gastric cancer, endometrial cancer, pancreatic ductal adenocarcinoma.

Merus overview

Merus is a clinical-stage oncology company that develops innovative antibody therapeutics. The company utilizes the Multiclonics, Biclonics and Triclonics platforms to develop human bispecific and tri-specific antibodies. Its pipeline products include petosemtamab (MCLA-158), a low-fucose human full-length IgG1 antibody that targets head and neck squamous cell carcinoma (HNSCC); MCLA-129 and MCLA-145 targeting advanced non-small cell lung cancer (NSCLC) and solid tumors; Zenocutuzumab (MCLA-128), antibody-dependent cell-mediated cytotoxicity (ADCC) drug for non-small cell lung cancer and pancreatic cancer; ONO-4685 for refractory T cell lymphoma and psoriasis; and INCA32459 and INCA33890 for advanced malignancies and select advanced solid tumors. The company operates through its subsidiaries in the Netherlands and the US. Merus is headquartered in Utrecht, the Netherlands.

For a complete picture of Zenocutuzumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.