Morphosys AG and Xencor, Inc. Provide Update on Phase 1/2a Trial in CLL/SLL for MOR208


Monday, 7 Oct 2013 01:31am EDT 

Morphosys AG and US-based Xencor, Inc. announced completion of the phase 1/2a clinical trial evaluating MOR208 (formerly XmAb(R)5574) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL/SLL). Safety and objective response data following the protocol defined eight-week treatment period was presented at the American Society of Hematology Annual Meeting in December 2012. Due to signs of activity of MOR208 in this difficult to treat patient population, the study protocol was amended to allow those patients in the highest dose group benefitting from the treatment to enter a prolonged treatment group. The final study results including the extended treatment arm showed an overall response rate of 29.6% (according to IWCLL 2008 criteria) based on the safety population of the trial (n=27) - up from the previously reported 14.8%. The phase 1/2a trial was designed to assess the drug's safety, tolerability, pharmacokinetic profile and preliminary anti-tumor activity. MOR208 was administered as an intravenous infusion on days 1, 4, 8, 15, and 22 of cycle 1, and on days 1, 8, 15, and 22 of cycle 2. Dose levels tested ranged from 0.3 to 12 mg/kg. Clinical responses were assessed according to International Working Group on CLL (IWCLL) Guidelines. Eight patients qualified for the extended treatment group and received up to four additional treatment cycles with MOR208 including prolonged additional disease response assessments. 

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