Tafasitamab is under clinical development by MorphoSys and currently in the 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 Tafasitamab’s likelihood of approval (LoA) and phase transition for Mantle Cell Lymphoma took place on 08 Aug 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Tafasitamab overview

Tafasitamab (Monjuvi/Minjuvi) is a humanized monoclonal antibody. It is formulated as lyophilized powder for solution and powder for concentrate for solution for intravenous route of administration. Monjuvi is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab (MOR-208, XmAb5574) is under development for the treatment of B cell malignancies including relapsed or refractory non-Hodgkin lymphoma, relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), other indolent NHL, nodal marginal zone B-Cell lymphoma, splenic marginal zone B-Cell lymphoma, Philadelphia chromosome-negative (Ph-) b-cell lymphoblastic lymphoma/leukemia (B-ALL) and extranodal marginal zone B-Cell lymphoma. It is a humanized monoclonal antibody. The drug candidate is administered as intravenous infusion. MOR-208 targets the antigen CD19. MOR-208 contains a proprietary Xencor XmAb Fc domain that enhances cytotoxic potency and also down-regulates B cell activation. It was also under development for refractory or relapsed acute lymphocytic leukemia(ALL).

MorphoSys overview

MorphoSys is commercial-stage biopharmaceutical company that develop monoclonal antibodies for therapeutic and research applications, with focused on the treatment of cancer and autoimmune diseases. The company’s product pipeline includes tafasitamab, pelabresib, cpi-0209, gantenerumab, otilimab, ianalumab, abelacimab, felzartamab, setrusumab, NOV-8, NOV-14 and MOR210. Its Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody directed against CD19 in clinical development for the treatment of B cell malignancies. The company provides clinical trials for cancer and inflammatory disorders. MorphoSys also conducts research and development activities with pharmaceutical and biotechnology companies. The company owns a regional licensing agreement to develop and commercialize products. It operates in the US. MorphoSys is headquartered in Planegg, Bayern, Germany.

Quick View Tafasitamab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tafasitamab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
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.