MorphoSys AG has announced that the first patient has been dosed in the safety evaluation phase of a phase 2/3 combination trial of MOR208 with bendamustine. The B-MIND trial (Bendamustine-MOR208 IN DLBCL) will evaluate the safety and efficacy of MOR208 combined with the chemotherapeutic agent bendamustine in comparison to rituximab plus bendamustine. The randomized international study will enroll adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation.
DLBCL is the most common form of non-Hodgkin's lymphoma (NHL). Following the phase 2 safety evaluation part, the study is expected to be transitioned into a pivotal phase 3 part in 2017. The investigational drug MOR208 is an Fc-enhanced monoclonal antibody targeting CD19, and is being developed for the treatment of patients with B cell malignancies.
"We are truly excited to begin the phase 2/3 B-MIND trial with MOR208 in DLBCL, which we aim to transition into MorphoSys's first pivotal study with an antibody from our proprietary pipeline next year. CD19 is a potential target in B cell malignancies and, coupled with MOR208's proprietary antibody design, we aim at developing MOR208 as a new treatment option for patients with a high unmet medical need," said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys.
"With the start of the B-MIND clinical trial, we now have two combination studies ongoing with MOR208 in relapsed/refractory DLBCL. We are encouraged by the results we have seen so far in patients treated with MOR208 as a single agent in our earlier clinical trials and we look forward to more data coming from our combination trials." The randomized, double-arm, open-label, multicenter phase 2/3 B-MIND study is expected to enroll approximately 330 patients in about 180 centers in Europe, Asia Pacific (APAC) and the USA.
At the time of study entry, patients must present with relapsed or refractory DLBCL, which has previously been treated with at least one and not more than three prior lines of therapy, including one anti-CD20 targeting therapy (e.g. rituximab). Patients must not be eligible for high-dose chemotherapy and autologous stem cell transplantation. The phase 2 safety evaluation part of the study will assess the safety and tolerability of MOR208 plus bendamustine vs. the rituximab plus bendamustine combination, enrolling approximately 10 patients in each treatment arm.
Following the safety evaluation part, the trial is intended to be transitioned into the pivotal phase 3 part, expected to start in 2017. The primary endpoint of the study is progression-free survival (PFS). Secondary outcome measures will include objective response rate (ORR), duration of response (DoR), overall survival (OS), disease control rate (DCR), time to progression (TTP) as well as an evaluation of patients' quality of life (QoL).