OREANDA-NEWS. Case study from clinical phase 2a trial with MOR208 in relapsed/refractory NHL published in the Journal of Medical Case Reports

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced that a case study report from an ongoing clinical phase 2a study with its proprietary drug candidate MOR208 in patients with different subtypes of relapsed or refractory non-Hodgkin's lymphoma (NHL) has been published in the Journal of Medical Case Reports.

The case report shows that 3rd line monotherapy with the anti-CD19 antibody MOR208 has resulted in an ongoing complete response (CR), of currently more than 26 months' duration, in a patient suffering from a morphological variant of diffuse large B-cell lymphoma (DLBCL). DLBCL - an aggressive type of blood cancer where B cells from the body's immune system become malignant - is the most common form of NHL. As further reported, quality of life and performance status of the patient have remained high under MOR208 therapy, as evaluated by WHO grade 0 and Karnofsky score of 100%. MOR208 could be administered on an out-patient basis. Before being enrolled in the study with MOR208, the patient had a very dismal prognosis after early relapse to two prior lines of treatment, both including chemotherapy in combination with an anti-CD20 therapy with rituximab.

"Patients with NHL, who are refractory or show early relapse after previous therapies containing anti-CD20 treatment, have very limited treatment alternatives and usually a very poor prognosis. This reported case is one out of several examples of heavily pre-treated blood cancer patients showing long-lasting and still ongoing complete responses under anti-CD19 treatment with MOR208. This further encourages us to develop MOR208 as a potential new therapy for patients suffering from B cell malignancies, in particular DLBCL, in phase 2 combination studies," said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

As previously reported, in the DLBCL subgroup overall response rate (ORR) was 36% (based on evaluable patients). In DLBCL, median duration of response (Kaplan-Meier estimates) was 20 months with three ongoing responses of up to more than 26 months. Patient evaluation and data analysis of the clinical phase 2a trial are ongoing. 92 patients were enrolled in the trial.

MOR208 is an anti-CD19 antibody with a proprietary modification to the Fc portion in clinical development to treat B cell malignancies.

An open-label, phase 2a, multicenter study was designed to assess the activity and safety of weekly doses of 12 mg/kg MOR208 as a single agent in 92 pre-treated patients with various subtypes of relapsed/refractory NHL patients including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL) including follicular lymphoma (FL). All patients had received at least one prior rituximab-containing therapy. According to the data observed, MOR208 showed a low level of infusion reactions. According to a subgroup analysis data presented at the ASCO 2016 annual meeting, a disease control rate (CR + PR + SD) of 40% in DLBCL and 73% in iNHL patients was observed. Progression-free survival (PFS) with MOR208 therapy was shown to be comparable in rituximab refractory and non-refractory NHL patients (median PFS 5.3 versus 6.6 months, HR 0.85, 95% CI 0.45-1.6, p=0.59) thus demonstrating in this trial an activity of MOR208 independent of the response to a prior anti-CD20 therapy. Updated data for the overall trial population furthermore revealed that after 12 months the PFS rate was 40% in both DLBCL and iNHL patients. Nine patients treated with MOR208 were still in remission (7 CRs, 2 PRs), the longest responses currently ongoing for 26 months. The overall response rate (ORR) of MOR208 reached 36% in the DLBCL subgroup and 33% in iNHL patients (both based on evaluable patients). Based on all patients with DLBCL and iNHL in the study, the ORR was 26% and 29%, respectively.

In April 2016, the first patient was dosed in a phase 2 combination trial (L-MIND study) investigating safety and efficacy of MOR208 in combination with lenalidomide in 80 patients with relapsed or refractory DLBCL. Furthermore, MorphoSys in 2016 plans to start the safety part of a clinical trial evaluating MOR208 in combination with the chemotherapeutic agent bendamustine in DLBCL which is intended to lead into a pivotal study to start in 2017. In addition, at the ASCO 2016 Annual Meeting the trial design of a phase 2 study with MOR208 was presented which trial is planned to evaluate MOR208 in combination with idelalisib in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients no longer responding to or no longer tolerating Bruton's tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib). After the discontinuation of several combination trials of idelalisib with other compounds, this planned trial is currently under review and discussions with regulatory authorities are ongoing. MorphoSys is currently exploring alternative study designs to evaluate MOR208 in a combination trial in CLL/SLL patients previously treated with a BTK inhibitor.

MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 100 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR.