Date: 2016-12-13
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: MorphoSys (Germany)
Product: MOR208 and idelalisib
Action
mechanism: kinase inhibitor/phosphoinositide 3-kinase (PI3K) inhibitor/monoclonal antibody. Zydelig® (idelalisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that plays a role in the activation, proliferation and viability of B cells. PI3K delta signaling is active in many B-cell leukemias and lymphomas, and by inhibiting the protein, Zydelig blocks several cellular signaling pathways that drive B-cell viability. 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 chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Therapeutic area: Cancer - Oncology
Country: Austria, Germany
Trial
details: The single-arm, open-label, multicenter COSMOS study will enroll patients in Europe and in the USA. Patients will receive intravenous infusions of MOR208 for up to 24 cycles of 28 days each. Idelalisib is taken orally, 150 mg twice-daily for the study duration. The study will include a safety run-in phase consisting of a safety evaluation by an independent data monitoring committee (IDMC). The study's primary endpoint is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR). Secondary outcome measures include progression-free survival (PFS), overall survival (OS) and duration of response (DoR), as well as an evaluation of the drug combination's safety and pharmacokinetic parameters of MOR208. (NCT02639910)
Latest
news: * On December 13, 2016, MorphoSys announced that the first patient was dosed in a Phase 2 combination trial of MOR208 with idelalisib (Zydelig®). The trial, which has been named COSMOS (CLL patients assessed for ORR & Safety in MOR208 Study), is designed to evaluate the safety and efficacy of MOR208 in combination with the PI3K delta inhibitor idelalisib in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Patient enrolled must have been refractory or shown relapse or intolerance to a prior, most recent, therapy with a Bruton's Tyrosine Kinase (BTK) inhibitor (ibrutinib).
