Clinical Trials

* On June 17, 2016, MorphoSys 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). 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. 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.
The patient, a 33 year-old male suffering from T-cell/histiocyte-rich large B-cell lymphoma, a morphological variant of DLBCL, had previously experienced early relapses after both, first-line treatment with rituximab combined with chemotherapy (R-CHOP) (relapse after 5 months) and second-line salvage chemotherapy including rituximab consolidated with an autologous stem-cell transplant (relapse after 6 months). Subsequently, the patient has been enrolled in the phase 2a trial of single-agent MOR208. In the study, the patient was treated for 12 weeks with 12mg/kg MOR208, administered intravenously once a week, followed by an ongoing maintenance therapy with administration of MOR208 every second week. Three months after starting 3rd line treatment with MOR208, the patient PET-CT assessments demonstrated a partial response (PR). Nine months later, during the ongoing maintenance therapy, PET-CT confirmed a complete response (CR). As stated in the case report, the patient experienced only few adverse events, which were all limited to infections of the respiratory tract. The quality of life and performance status of the patient has remained high during treatment, as measured by WHO grade 0 and Karnofsky score of 100%, with MOR208 treatment being administered on an out-patient basis. The patient's complete response is ongoing, with a current duration of more than 26 months (24 months duration at the time of manuscript acceptance). 

* On December 7, 2015, MorphoSys announced presentation of clinical data on MOR208 at the 2015 American Society of Hematology (ASH) Annual Meeting. The data 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.  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% across all four subtypes of NHL and reached 36% 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. Clinical trials of the combination of MOR208 with other anti-lymphoma therapies (e.g. lenalidomide and bendamustine) will commence shortly.

* On June 1, 2015, MorphoSys announced presentation of updated clinical data from  an ongoing phase 2a study of MOR208 at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The study involves patients with four different subtypes of relapsed or refractory Non-Hodgkin's Lymphoma (NHL). The clinical data show that MOR208 is well tolerated with a low level of infusion reactions and demonstrates encouraging single-agent activity. 
The preliminary data presented  summarize efficacy and safety results for 92 heavily pre-treated patients. The overall response rate was 28% across all four subtypes of NHL and reached 36% in the DLBCL subgroup (both based on evaluable patients). At the time of the analysis, the majority of responders - 16 out of 21 - had an ongoing response to the treatment. The longest response duration observed so far exceeded 14.2 months in DLBCL, 15.4 months in FL and 10.8 months in other iNHL.
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, responding patients, who demonstrated at least partial response received maintenance therapy until disease progression or unacceptable toxicity.

Investigator assessed response in the NHL subtype specific cohorts 

*Overall Response Rate (ORR) = Number of complete responses + partial responses versus total
** Patients that have completed two cycles of treatment and subsequently received disease response assessment
DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; iNHL, indolent non-Hodgkin's lymphoma; MCL, mantle cell lymphoma; NHL, non-Hodgkin's lymphoma; pts, patients
The ASCO presentation is titled: "Phase 2a study of single-agent MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL)".Based on these  results, MorphoSys plans to advance MOR208 into two combination trials in DLBCL.

* On December 8, 2014, MorphoSys announced promising clinical data on its proprietary drug candidate MOR208 from a phase 2a study in 89 patients with four different subtypes of relapsed or refractory Non-Hodgkin's Lymphoma (NHL). 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 preliminary clinical data, which were presented at the 56th Annual Meeting of the American Society of Hematology (ASH), show that MOR208 is well tolerated with a low level of infusion reactions and demonstrates encouraging single-agent efficacy. The open-label, phase 2a, multicenter study was designed to assess the efficacy 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 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, responding patients (complete or partial response) received maintenance therapy until progression. The study used a two-stage design. In stage 1, approximately ten patients were enrolled in each of the four NHL subtypes. The DLBCL and FL cohorts which saw two or more responses (complete or partial response) in stage 1 were expanded in stage 2. The data presented at ASH summarizes efficacy and safety results for 89 patients enrolled as of 17 November 2014 in stages 1 and 2 of this trial.

Investigator assessed response in the NHL subtype specific cohorts

* On May 13, 2013, MorphoSys has announced that it has dosed the first patient in a Phase 2 clinical trial of MOR208 in Non-Hodgkin's Lymphoma (NHL).MOR208 showed encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in a Phase 1/2a trial in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In addition to the phase 2 trial in NHL, MorphoSys is currently evaluating the compound in a phase 2 trial in B-cell Acute Lymphoblastic Leukemia (B-ALL).