Margetuximab is under clinical development by MacroGenics and currently in Phase I for Extrahepatic Bile Duct Cancer. According to GlobalData, Phase I drugs for Extrahepatic Bile Duct Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Margetuximab LoA Report. 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.

Margetuximab overview

Margetuximab (Margenza) is a Fc-engineered human epidermal receptor growth factor-2 directed IgG1 kappa monoclonal antibody. It is the biobetter version of trastuzumab. It is formulated as injectable solution for intravenous route of administration. Margenza is indicated in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior HER2 regimens, at least one of which was for metastatic disease.
Margetuximab (MGAH22) is under development for the treatment of solid tumor, small-cell lung cancer, non-small cell lung cancer, metastatic breast cancer, gastroesophageal cancer, adenocarcinoma of the gastroesophageal junction, epithelial ovarian cancer, hepatocellular carcinoma (HCC), SCCHN, metastatic cervical cancer, TNBC, intrahepatic bile duct epithelial cell carcinoma (Metastatic Bile Duct Cancer), Extrahepatic Bile Duct Cancer, gallbladder cancer and gastric cancer. The therapeutic candidate is monospecific, bivalent and it’s half life last from days to weeks. It is also under development for the treatment of relapsed/refractory advanced HER2+ gastroesophageal junction or gastric cancer. The therapeutic candidate is administered by intravenous infusion. It is a HER2 mAb with specificity and affinity similar to trastuzumab. It was also under development for colorectal cancer, head and neck cancer. It is derived from the Fc Optimization technology platform.

It was also under development for the treatment of diffuse large B-cell lymphoma.

MacroGenics overview

MacroGenics is a biopharmaceutical company which focuses on the development and delivery of novel antibody-based therapeutics for the treatment of cancer, infectious diseases and autoimmune disorders. Its product pipeline includes candidates for the treatment of solid tumors, HIV, breast and gastroesophageal cancers, type 1 diabetes, DART product candidates for the treatment of acute myeloid leukemia and myelodysplastic syndrome; and b-cell malignancies. The company’s product candidates are based on proprietary technology platforms, namely, Cancer Stem Cell Platform, Dual-Affinity Re-Targeting (or DART) and TRIDENT Platform and FC Optimization Platform. It works in collaboration with various pharmaceutical and biotechnology companies to leverage its technology platforms and protein engineering capabilities for development. MacroGenics is headquartered in Rockville, Maryland, the US.

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

This content was updated on 7 February 2024

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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.