MorphoSys AG has announced that the first patient was dosed in a phase 2 combination trial of MOR208 with lenalidomide (Revlimid®) to evaluate the safety and efficacy of MOR208 in combination with the immunomodulatory drug lenalidomide in adult subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma (NHL).
MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion, and is being developed to treat B cell malignancies. The single-arm, open-label, multicenter L-MIND study is expected to enroll 80 patients in 56 centers in 9 European countries and the USA. At the time of study entry, patients must present with relapsed or refractory DLBCL, which had previously been treated with at least one and not more than two prior lines of therapy, including one anti-CD20 targeting therapy (e.g. rituximab).
Patients must not be candidates for high-dose chemotherapy with autologous stem cell transplantation. Patients will receive weekly intravenous infusions of 12mg/kg MOR208 for 12 weeks, followed by administration every second week for up to 2 years or until disease progression or unacceptable toxicity, whichever comes first. In addition to MOR208, lenalidomide will be administered orally, for up to one year.
The study's primary end point is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS), as well as an evaluation of the drug combination's safety and pharmacokinetic parameters of MOR208.
"We are pleased to kick off the L-MIND trial as the first in a series of planned clinical studies evaluating combination therapies with MOR208 in hemato-oncological indications with high medical need. MOR208 has already demonstrated very encouraging single-agent activity and was well tolerated by patients in our phase 2a NHL trial as presented at the ASH 2015 conference in December 2015. In addition, an ongoing Phase 2 investigator-initiated trial has already shown good preliminary safety and activity of the combination of MOR208 and lenalidomide in patients suffering from chronic lymphocytic leukemia (CLL). These recent findings encourage us to explore the therapeutic potential of MOR208 in different combinations", said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.