Tafasitamab is under clinical development by MorphoSys and currently in Phase II for Leukemia. According to GlobalData, Phase II drugs for Leukemia have a 34% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Tafasitamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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.

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 a commercial-stage biopharmaceutical company that develops monoclonal antibodies for therapeutic and research applications, with a focus 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.

For a complete picture of Tafasitamab’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.