Tafasitamab is under clinical development by Incyte and currently in Phase III for Marginal Zone B-cell Lymphoma. According to GlobalData, Phase III drugs for Marginal Zone B-cell Lymphoma have a 57% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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.

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).

Incyte overview

Incyte is a biopharmaceutical company, that discovers, develops and commercializes proprietary cancer therapeutics. The company’s lead product, Jakafi (ruxolitinib) is marketed in the US for the treatment of patients with high-risk myelofibrosis; and polycythemia vera who are intolerant to hydroxyurea. The company distributes Jakafi through a network of specialty pharmacy providers and wholesalers. In collaboration with Incyte, Novartis International Pharmaceutical Ltd (Novartis) develops and commercializes ruxolitinib outside the US for hematologic and cancer indications under the name Jakavi. The company’s pipeline portfolio encompasses drugs for the treatment of lung cancer, graft versus host disease, b-cell malignancies, solid tumors, non-small cell lung cancer, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.

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

This content was updated on 10 June 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.