MorphoSys AG announced clinical data on its proprietary drug candidate MOR208. MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion that is being developed to treat B cell malignancies.
The data, which were presented at the 2015 American Society of Hematology (ASH) Annual Meeting, are from a phase 2a monotherapy study of patients with different subtypes of relapsed or refractory Non-Hodgkin's Lymphoma (NHL) and another phase 2 study where MOR208 is tested in chronic lymphocytic leukemia (CLL) in combination with lenalidomide. Clinical trials of the combination of MOR208 with other anti-lymphoma therapies (e.g. lenalidomide and bendamustine) will commence shortly.
"The MOR208 data presented at ASH provide further confirmation for the potential of MOR208 to become an important treatment option in a field with significant unmet need," commented Dr. Arndt Schottelius, chief development officer of MorphoSys AG.
"Encouraging single-agent activity together with a long duration of response as a single agent in patients with relapsed/refractory NHL bodes well for additional combination trials in DLBCL and CLL."
The open-label, phase 2a, multicenter study was designed to assess the activity and safety of single-agent MOR208 in patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL), who had received at least one prior rituximab-containing therapy. Patients were initially treated with a total of eight weekly doses of 12 mg/kg MOR208. Those with at least stable disease stayed on MOR208 treatment for an additional four weeks. After completion of these twelve weekly doses of treatment, those patients who demonstrated at least a partial response received maintenance therapy until disease progression or unacceptable toxicity.
The data for the NHL phase 2a monotherapy study presented at ASH 2015 summarize efficacy and safety results for 92 heavily pre-treated patients. The clinical data show that MOR208 is well tolerated with a low level of infusion reactions and demonstrates encouraging single-agent activity. The overall response rate was 28 per cent across all four subtypes of NHL and reached 36 per cent in the DLBCL subgroup (both based on evaluable patients). At the time of the analysis, several responders - 9 out of 21 - had an ongoing response to the single agent treatment. Median progression-free survival for all subtypes of NHL tested in the study amounted to 6 months. The longest response duration observed so far exceeded 20 months in both DLBCL and FL.
A second presentation, from investigators at The Ohio State University, reported on an investigator-initiated trial (IIT) of combinations of MOR208 with lenalidomide in relapsed/refractory or treatment-naive CLL patients. Patient accrual in both cohorts is ongoing; so far 16 patients have been enrolled and 11 patients have been evaluated. The combination of MOR208 with lenalidomide has been well tolerated. Three partial responses and two stable diseases were observed in the relapsed/refractory cohort and four partial responses in the treatment-naïve cohort so far. Responses have generally deepened over time, with five patients completing 12 cycles of therapy. This study has recently been amended to include patients with Richter's transformation and to add MOR208 to ibrutinib in patients undergoing molecular relapse.
"There is a high unmet medical need for CLL patients, especially following discontinuation after ibrutinib therapy," said Dr. Jennifer Woyach, assistant professor of internal medicine at Ohio State University.
"We just recently added additional cohorts to our ongoing CLL study to evaluate MOR208 in combination with ibrutinib as we see MOR208 as a promising combination partner in this setting."