Cusatuzumab is under clinical development by Argenx and currently in the Phase I and Phase II 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 Cusatuzumab’s likelihood of approval (LoA) and phase transition for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) took place on 21 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 21 Dec 2022 increased Cusatuzumab’s Phase Transition Success Rate (PTSR) for Myelodysplastic Syndrome.

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

Cusatuzumab overview

Cusatuzumab (ARGX-110) is under development for the treatment of solid tumors, such as renal cell carcinoma, acute promyelocytic leukemia, platinum-refractory ovarian cancer, head and neck cancer, nasopharyngeal carcinoma, myoepithelial carcinoma, mesothelioma and hematological malignancies including refractory Waldenstrom’s macroglobulinemia (WM), relapsed/refractory T-cell lymphomas such as Sezary syndrome (cutaneous T-cell lymphoma), angioimmunoblastic T-cell lymphoma (AITL), acute myeloid leukemia(AML) and high risk myelodysplatic syndrome. The therapeutic candidate is administered through intravenous or subcutaneous route. It is a glyco-engineered fully human antibody developed based on SIMPLE antibody platform. ARGX-110 is equipped with Potelligent to enhance its ability to destroy CD70-positive tumor cells. The drug candidate was also under development for chronic myelocytic leukemia (CML), inflammatory and autoimmune disorders.

Argenx overview

Argenx is an immunology company that focuses on the development of human antibodies. The company is primarily developing products for autoimmune diseases. Its key product includes VYVGART, a neonatal Fc receptor blocker, which is used to treat generalized myasthenia gravis in adults which are anti-acetylcholine receptor (AChR) antibody positive. The company’s pipeline products include Efgartigimod, ARGX-117, Cusatuzumab, ARGX-118, ARGX-119 and ARGX-120. Argenx in partnership with Leo Pharma, AgoMab, AbbVie and Staten has been licensed to develop products such as ARGX-112, ARGX-114 and ARGX-115. The company develops antibodies using its proprietary technology platforms such as NHance, simple antibody technology, and others. It operates offices in the Netherlands, the United States, Japan, Switzerland and Belgium. Argenx is headquartered in Breda, the Netherlands.

Quick View Cusatuzumab LOA Data

Report Segments
  • Innovator
Drug Name
  • Cusatuzumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Oncology
Key Developers
Highest Development Stage
  • Phase II


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.