MorphoSys Updates On L-MIND And B-MIND Trials Of MOR208 In R/R DLBCL

(RTTNews) - MorphoSys AG (MOR) provided updates on L-MIND and B-MIND, its two ongoing clinical trials of the investigational Fc-enhanced anti-CD19 antibody MOR208 in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

The L-MIND trial, the Company's single-arm, open-label study investigating MOR208 in combination with lenalidomide, has completed enrollment and data are currently being analyzed. Topline results are expected to be released at a medical conference in mid-2019.

The company said it intends to use L-MIND as the basis for a regulatory filing to the FDA, which it expects to complete by the end of this year. In parallel, the Company has initiated discussions with National European Regulatory Authorities to explore the possibility of using the L-MIND study as the basis for the submission of a potential marketing authorization application (MAA) in Europe. If the European Medicines Agency (EMA) were to agree to accept a potential MAA based on L-MIND, submission of such an MAA could occur earlier than originally anticipated based on the B-MIND trial. MorphoSys is seeking scientific advice from EMA in the forthcoming months.

The B-MIND study, which compares MOR208 in combination with bendamustine versus rituximab plus bendamustine, continues as originally designed.

Additionally, during the first quarter of 2019 and in agreement with the FDA, MorphoSys implemented an amendment of the B-MIND study. The scientific rationale for the amendment is based on published literature as well as MorphoSys's own pre-clinical data, which indicate that MOR208 might be particularly active in patients who can be characterized by the presence of a certain biomarker. The amended B-MIND trial may serve, in addition to being potentially pivotal on its own, as a confirmatory study if conditional approval of MOR208 is granted based on L- MIND.

The company noted that discussions with the FDA regarding the biomarker assay are currently being planned and are expected to take place in the middle of this year. The pre-planned, event-driven interim analysis of B-MIND remains projected to take place in the second half of 2019. Depending on the outcome of the interim analysis, an increase from 330 to 450 patients may be required, in which case an event-driven primary analysis of the study is expected in the first half of 2021.