Morphosys has said that an independent data monitoring committee (IDMC) recommended increasing the size of tafasitamab’s Phase III B-MIND clinical trial.
Tafasitamab is designed as a humanised Fc-engineered monoclonal antibody to target CD19, which is expressed on various B-cell malignancies.
B-MIND is a Phase II/III trial assessing tafasitamab in combination with bendamustine, a chemotherapeutic agent, in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL).
The investigational drug combination was compared to rituximab, an anti-CD20 antibody, and bendamustine combination.
Patients not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) were recruited to participate in B-MIND.
At interim analysis for futility, the IDMC reviewed efficacy data from the overall patient population and the biomarker-positive subpopulation. A low peripheral blood natural killer cell count at baseline was considered as a biomarker.
Based on the results, the committee recommended the company to boost the number of participants from 330 to 450 to increase the study’s statistical power.
MorphoSys said that the analysis data was not shared with the company. Top-line data from the trial are expected to be reported in the first quarter of 2022.
MorphoSys chief development officer Dr Malte Peters said: “DLBCL is a difficult to treat disease and has a high unmet medical need, so new treatment options are highly needed.
“Independent of B-MIND, we are on track to complete our BLA submission to the US FDA for tafasitamab in combination with lenalidomide by the end of 2019 based on the previously reported encouraging results from the L-MIND and Re-MIND clinical studies.”
Tafasitamab in combination with lenalidomide is also undergoing an open-label Phase II trial in relapsed/refractory DLBCL patients. It is being further studied in combination with idelalisib or venetoclax to treat relapsed/refractory CLL/SLL.