Margetuximab is under clinical development by MacroGenics and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Margetuximab’s likelihood of approval (LoA) and phase transition for Solid Tumor took place on 27 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Margetuximab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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, diffuse large B-cell lymphoma, 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.

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, breast and gastroesophageal cancers, type 1 diabetes, HIV, 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.

Quick View Margetuximab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Margetuximab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: MacroGenics
  • Originator: Raven biotechnologies
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.