Micrograph of a diffuse large B cell lymphoma. Credit: Nephron.

MorphoSys‘ ongoing single-arm Phase II clinical trial of tafasitamab (MOR208) in combination with lenalidomide to treat relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) has met its primary endpoint.

The L-MIND trial enrolled a total of 80 patients with r/r DLBCL who are ineligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

The subjects were given tafasitamab and lenalidomide and followed-up for at least one year.

MorphoSys noted that the patients had an average age of 72 years and received a median of two prior treatment lines.

MorphoSys chief development officer Dr Malte Peters said: “We are very pleased by the results from the primary analysis of the L-MIND study and are especially encouraged by the durability of the responses and the OS that we are seeing.

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“If approved, we believe that with tafasitamab in combination with lenalidomide we can offer a chemo-free treatment option to patients with r/r DLBCL who are ineligible for HDC and ASCT.”

As part of the L-MIND trial, the investigational humanised Fc-enhanced monoclonal antibody tafasitamab was investigated in combination with lenalidomide in patients with r/r DLBCL.

Tafasitamab, which is directed against CD19, is currently in clinical development in blood cancer indications.

The primary endpoint is defined as the best objective response rate (ORR). The ORR was 60% and the complete response (CR) rate was 43%.

In the trial, efficacy parameters, such as response rates, showed comparable results in most patient subgroups of interest.

The company plans to complete a BLA submission to the FDA by the end of this year.