MorphoSys expects to report top-line data from the B-MIND trial in 2022. Credit: MorphoSys AG.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.