MorphoSys has presented safety and efficacy data from an ongoing phase 2 clinical trial ("L-MIND" study) evaluating MOR208 in combination with lenalidomide in patients with relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL). DLBCL is the most common form of non-Hodgkin's lymphoma. Data were reported during a poster presentation at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago/USA. MOR208 is an Fc-enhanced investigational antibody directed against CD19.
"We are very excited having seen the preliminary data from the first 44 patients of our ongoing phase 2 L-MIND trial. We are particularly optimistic about the level of response rates that we have seen so far, especially complete responses. For DLBCL patients who relapse after their first-line treatment, current treatment options are very limited. We are therefore exploring potential new treatment regimens with MOR208 for this difficult-to-treat patient group", commented Dr. Malte Peters, chief development officer of MorphoSys AG.
44 patients were enrolled in the study at data cut-off, 34 of whom were evaluable for efficacy assessment. Preliminary data show an objective response in 19 out of 34 patients (ORR: 56%). Complete remission was seen in 11 out of 34 patients (CR: 32%). 16 out of 19 patients in whom responses were recorded, were still on study at time of data-cut off.
No infusion-related reactions were reported for MOR208. The most frequent adverse events observed of grade 3 or higher were hematological, comprising neutropenia, thrombocytopenia, and leukopenia, seen in 32%, 9% and 9% of patients, respectively. To date, 27% of patients required a reduction of the lenalidomide dose due to side effects. No unexpected safety-related effects were observed.
The L-MIND trial (Lenalidomide plus MOR208 in DLBCL) is a single-arm, open-label, multicenter study of MOR208 in combination with lenalidomide. The trial will enroll approximately 80 patients with relapsed or refractory DLBCL after up to three prior lines of therapy, with at least one prior therapy including an anti-CD20 targeting therapy (e.g. rituximab). Patients in the trial could not be candidates for high-dose chemotherapy or autologous stem cell transplantation. Patients enrolled in the trial had a median age of 73 years.
In addition to the preliminary data from the phase 2 L-MIND study with MOR208 and lenalidomide in R/R DLBCL, two "trial-in-progress" posters about MOR208 were presented at ASCO 2017 illustrating the study designs of two other ongoing clinical combination trials of MOR208: the phase 2/3 randomized, "B-MIND" study comparing MOR208 plus bendamustine vs. rituximab plus bendamustine in patients with R/R DLBCL; and the phase 2 "COSMOS" study in R/R chronic lymphocytic leukemia (CLL) patients, who had previously discontinued treatment with a Bruton tyrosine kinase (BTK) inhibitor. The COSMOS trial is currently investigating MOR208 in combination with idelalisib.