MorphoSys planning BLA for DLBCL candidate on Phase II data

MorphoSys AG (Xetra:MOR; Pink:MPSYY) said it discussed with FDA the possibility of expedited regulatory submission and approval for its MOR208 (MOR00208) to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL) "based primarily" on data from the Phase II L-MIND trial in the indication. The company, which plans to submit a rolling BLA to FDA in 2H19 for MOR208, reported updated data from L-MIND.

Among 68 evaluable patients ineligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT) in the open-label trial, IV MOR208 plus Revlimid lenalidomide led to a preliminary 12-month progression-free survival (PFS) rate of 50.4%. Preliminary median PFS has not yet been reached. MOR208 plus Revlimid led to an overall response rate (ORR) of 49%, including a complete response rate of 31%. Median time to response was 1.8 months and median time to complete response was 3.6 months...