Date: 2017-06-02
Type of information: Initiation of patient enrollment
phase: 2-3
Announcement: initiation of patient enrollment
Company: MorphoSys (Germany)
Product: MOR208 plus bendamustine
Action mechanism: monoclonal antibody. MOR208 (formerly XmAb®5574) is a potent anti-CD19 antibody with a proprietary modification to the Fc portion, that is being developed to treat B-cell malignancies.The target molecule CD19 is expressed more broadly and earlier in B-cell development than CD20, the target of the marketed cancer drug Rituxan®. Therefore targeting CD19 could potentially allow for an even broader therapeutic use of MOR208 than marketed anti-CD20 antibodies. In June 2010, MorphoSys and Xencor signed a worldwide exclusive license and collaboration agreement. The agreement provided MorphoSys with an exclusive worldwide license to MOR208 for the treatment of cancer and other indications. Using Xencor's XmAb Fc enhancement technology, MOR208 has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumor cell killing and offering potential for enhanced efficacy compared to traditional antibodies for the treatment of cancer.
Disease: patients with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL) who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT)
Therapeutic area: Cancer - Oncology
Country: Austria, Croatia, Czech Republic, Finland, France, Germany, Hungary, Italy, Republic of Korea, Poland, Portugal, Singapore, Spain, UK
Trial details: (NCT02763319)
Latest news: • On June 2, 2017, MorphoSys announced that the pivotal phase 3 part of the B-MIND clinical study of MOR208 has been opened for enrollment. The randomized, multicenter phase 2/3 study is designed to investigate the efficacy of MOR208 plus bendamustine versus rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL) who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on the available data from the phase 2 safety evaluation part of the B-MIND trial, the Independent Data Monitoring Committee (IDMC) supported the continuation of the trial as per protocol and the transition of the study into its pivotal phase 3 part. Patients must have been treated previously with at least one but not more than three prior lines of therapy, including one anti-CD20 targeted therapy. The study is expected to enroll a total of approximately 330 patients in about 180 centers in Europe, Asia Pacific (APAC) and the USA. The dosing of the first patient in the phase 3 part will trigger an undisclosed milestone payment to Xencor, from whom MOR208 was in-licensed in 2010. MorphoSys has worldwide rights to MOR208.
