Date: 2016-04-06
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: MorphoSys (Germany)
Product: MOR208 and lenalidomide
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 AG 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: relapsed or refractory diffuse large B cell lymphoma (DLBCL)
Therapeutic area: Cancer - Oncology
Country: Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, UK, USA
Trial details:
Latest
news: * On April 6, 2016, MorphoSys announced that the first patient was dosed in a phase 2 combination trial of MOR208 with lenalidomide (Revlimid®). The trial, which has been named L-MIND (Lenalidomide-MOR208 IN DLBCL), is designed to evaluate the safety and efficacy of MOR208 in combination with the immunomodulatory drug lenalidomide in adult subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma (NHL). The single-arm, open-label, multicenter L-MIND study is expected to enroll 80 patients in 56 centers in 9 European countries and the USA. At the time of study entry, patients must present with relapsed or refractory DLBCL, which had previously been treated with at least one and not more than two prior lines of therapy, including one anti-CD20 targeting therapy (e.g. rituximab). Patients must not be candidates for high-dose chemotherapy with autologous stem cell transplantation. Patients will receive weekly intravenous infusions of 12mg/kg MOR208 for 12 weeks, followed by administration every second week for up to 2 years or until disease progression or unacceptable toxicity, whichever comes first. In addition to MOR208, lenalidomide will be administered orally, for up to one year. The study's primary end point is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS), as well as an evaluation of the drug combination's safety and pharmacokinetic parameters of MOR208.
