The European Commission ( EC ) has granted conditional marketing authorization for Minjuvi ( Tafasitamab ) in combination with Lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma ( DLBCL ) who are not eligible for autologous stem cell transplant ( ASCT ).
The conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of Tafasitamab in combination with Lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant.
The results have shown best objective response rate ( ORR ) of 56.8% ( primary endpoint ), including a complete response ( CR ) rate of 39.5% and a partial response rate ( PR ) of 17.3%, as assessed by an independent review Committee.
The median duration of response ( mDOR ) was 43.9 months after a minimum follow up of 35 months ( secondary endpoint ).
Tafasitamab together with Lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable.
Warnings and precautions for Minjuvi include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity ( ADCC ) and Antibody-Dependent Cellular Phagocytosis ( ADCP ).
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases, and is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL.
In the United States, Monjuvi ( Tafasitamab-cxix ) is approved by the U.S. Food and Drug Administration ( FDA ) in combination with Lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( Xagena )
Source: Incyte, 2021