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Updated Results from Phase 2 Trial Demonstrate Prolonged Hematologic Relapse-Free Survival of Micromet's Blinatumomab in Patients with Acute Lymphoblastic Leukemia
Date:6/14/2010

ult patients with B precursor acute lymphoblastic leukemia.  Enrolled patients had sub-microscopic evidence of leukemic cells in the bone marrow following treatment with front-line chemotherapy, so called minimal residual disease (MRD). The primary endpoint of the study was MRD response. Key secondary endpoints included time to hematological relapse, time to molecular relapse and overall incidence and severity of adverse events.  Patients received 15 micrograms per meter squared per day of blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle.  

Phase 2 Results

21 patients were treated in this study.  Of 20 evaluable patients, 80% (16 out of 20) achieved a complete MRD response. Among the 13 non-transplanted patients, there were eight patients with non-Ph+ or t(4;11) disease. For these eight patients the median time to hematological relapse has not been reached at a median follow-up of 480 days.  For a similar group of patients with MRD positive disease treated with chemotherapy by the German Multicenter Adult ALL Study Group (GMALL), a median time to hematological relapse of approximately 200 days from diagnosis has been reported(1).

Eight of the patients in the study received an allogeneic transplant after blinatumomab treatment, all of whom are alive and in remission, ranging up to 21 months.  Overall, blinatumomab was well-tolerated. The most common adverse events (any grade) were fever, decreases of immunoglobulins, and headache.  Two patients discontinued treatment due to adverse events; seizure and syncope, respectively, with both events being completely reversible.  

"Historical experience suggests that there is a high mortality rate among patients with ALL who receive a stem cell transplant," said Dr. Topp. "Notably, no deaths or relapses have been
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SOURCE Micromet, Inc.
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