MorphoSys Presents Updated Clinical Data for Blood Cancer Candidate MOR208 in NHL and CLL at ASH 2016 Conference

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PFS was similar in patients with rituximab non-refractory versus rituximab refractory tumors. Fifty-two patients (57%) in the study were classified as having rituximab refractory disease. Of those, five of 24 patients (21%) with DLBCL and five of 22 patients (23%) with iNHL responded to MOR208. Of the 10 responders with rituximab refractory disease, six had a response duration longer than 10 months, two of which lasted for more than 26 months.

The most common adverse events were infusion-related reactions (IRRs) occurring in 12% of the patients (11% of grade 1 or 2, 1% of grade 4) and neutropenia occurring in 12% of patients (3% of grade 1 or 2, 9% of grade 3 or higher). No treatment-related deaths were reported.

Number and title of the presentation
Abstract #623
Jurczak et al: Single-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin's Lymphoma (NHL): Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study

Combination of MOR208 with lenalidomide and ibrutinib in CLL from phase 2 investigator-initiated trial

A second presentation is a poster from investigators at The Ohio State University, who reported on an investigator-initiated trial (IIT) evaluating MOR208 in combination with lenalidomide in three cohorts of patients with chronic lymphatic leukemia (CLL): previously untreated CLL patients, relapsed/refractory CLL patients; and patients with Richter's Transformation.

The trial also included a 4th cohort of ibrutinib-treated CLL patients with identified resistance mutations to ibrutinib in the tumors (molecular relapse) but no confirmed clinical relapse where MOR208 was added to ibrutinib therapy. Recent data have generally shown poor clinical outcomes in patients who relapse after a therapy with the BTK inhibitor ibrutinib and whose leukemia cells carry a mutation in the BTK gene prior to relapse.

According to the data presented, 34 patients have been enrolled in the study so far, 27 receiving MOR208 in combination with lenalidomide (11 of which in the previously untreated cohort, 11 in the relapsed/refractory cohort, 5 in the Richter's Transformation cohort) and 7 receiving MOR208 plus ibrutinib, with patient accrual still ongoing.

Most frequent hematological adverse event over all cohorts were thrombocytopenia in 47% of patients (9% grade 3 or higher) and neutropenia in 35% (21% grade 3 or higher). There were no unexpected serious adverse events reported.