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news.MorphoSys has completed the safety run-in phase of its clinical phase 2 study of MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma (NHL).
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Six patients have been administered MOR208 at the recommended dose (12mg/kg) in combination with lenalidomide during the safety run-in part of the L-MIND study. No unexpected safety signals were detected, and the study will continue as planned.
"We continue to investigate MOR208 in combination with lenalidomide as a potential treatment for patients with DLBCL. This is part of our broader initiative to develop MOR208 as an antibody backbone for a variety of combination partners. We are pleased with the initial safety run-in results from the L-MIND trial, which showed no unexpected safety signals," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
"The clinical trial is progressing as planned, and we expect to present first efficacy data in 2017."
L-MIND is a single-arm, open-label, multicenter study of the anti-CD19 antibody MOR208 in combination with lenalidomide enrolling approximately 80 patients with relapsed or refractory DLBCL after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab).
Patients must not be candidates for high-dose chemotherapy and autologous stem cell transplantation. The study's primary endpoint is overall response rate (ORR).
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.
About CD19 and MOR208
CD19 is broadly and homogeneously expressed across different B cell malignancies including DLBCL and CLL. CD19 enhances B cell receptor (BCR) signaling which is important for B cell survival – making CD19 a potential target in B cell malignancies.
MOR208 (previously Xmab®5574) is an Fc-enhanced antibody targeting CD19. Fc-enhancement of MOR208 leads to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Furthermore, MOR208 induces direct apoptosis by binding to CD19.
MorphoSys AG is investigating the targeting of BCR-associated CD19 with the Fc-enhanced antibody MOR208 as an immunotherapeutic option in B cell malignancies.
Updated data, presented at the 2016 annual meetings of the American Society of Clinical Oncology and European Hematology Association (ASCO, EHA 2016), presented the results of efficacy and safety studies of MOR208 as monotherapy in 92 heavily pre-treated NHL patients (non-Hodgkin's lymphoma).
The overall response rate (ORR) in evaluable patients was 36% in the diffuse large B cell lymphoma (DLBCL) and 33% in indolent NHL (iNHL) patients. At the time of the analysis, the median duration of response (DoR) (Kaplan-Meier estimates) in DLBCL was 20 months with 3 ongoing responses. Median DoR was not reached in iNHL patients with 72% of responders without disease progression at 16 months.
The 12-months PFS rate in DLBCL was 40% with similar PFS in both rituximab-sensitive and -refractory patients. The incidence of MOR208 treatment-related serious adverse events was 6% in DLBCL and 4% in iNHL patients. No treatment-related deaths were reported.