Dive Brief:
- MorphoSys AG reported updated data for its mid-stage Fc enhanced CD19 antibody, noting during an earnings call on Tuesday that it hopes to use this data for the basis of a regulatory filing with the Food and Drug Administration.
- The L-MIND trial tested MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial has fully enrolled the 81 patients specified in protocol and 68 were available for efficacy assessment as of the cut-off date.
- As of December 2017, the preliminary progression-free survival (PFS) rate at 12 months was 50.4%. It showed an overall response rate (ORR) of 49% for the very advanced, and largely elderly patient population, with 29 of 33 patients showing an ongoing response.
Dive Insight:
Based on the promising data in this challenging population, MorphoSys plans to seek accelerated approval and begin a rolling Biologics License Application (BLA), which could mean the drug is potentially approved by 2019.
"We consider these favorable safety findings as important. In particular, in the light of the elderly and frail patient population in whom toxicity [is] ... not well tolerated. We are also quite encouraged about the safety data of MOR208 when put into perspective with clinical data from other experimental treatments in this patient population," said MorphoSys Chief Development Officer Malte Peters in a Tuesday call with investors.
The biotech is also studying MOR208 plus bendamustine in a Phase 3 head-to-head study against Rituxan (rituximab) plus bendamustine, a common DLBCL treatment. It is currently on track to enroll 330 patients.
"We intend to build commercial capabilities in connection with the potential future approval of MOR208 and this process is ongoing. Our preferred option at this stage is to retain either sole or co-promotion rights in the U.S. and to partner elsewhere in order to execute our commercial strategy," added Simon Moroney, CEO of the German biotech.
"At this stage, we are working under the assumption that we will need to be ready to commercialize MOR208 starting in the first half of 2020. MOR208 also has potential on other lines of DLBCL treatment and in other B cell malignancies."