Micromet to present new data from its blinatumomab Phase 1 trial at the ASH meeting

Dec 7 2009

Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced the publication of a poster with new data from its ongoing phase 1 clinical trial of its product candidate blinatumomab in patients with non-Hodgkin's lymphoma (NHL) at the 51ST Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana. Blinatumomab is a CD19-specific, T cell-engaging BiTE® antibody designed to direct a patient's own T cells against cancer cells inducing a self-destruction process in cancer cells.

The new data presented at ASH show that 100 percent of evaluable patients (12 of 12 patients) with relapsed/refractory NHL, who were treated with blinatumomab at a dose level of 60 microgram/squaremeter per day, had an objective partial or complete response after their first 4-8 weeks of treatment. The responses were measured based on Cheson/IWG criteria and were confirmed by independent review. One patient at the 60-microgram dose level was not evaluable because of an adverse event that resulted in the discontinuation of treatment after two days. The longest duration of a response without re-treatment is currently 20 months. The response in 6 of the 12 evaluable patients is ongoing. The 60-microgram dose level has been selected for further clinical studies in patients with B-cell lymphoma.

At the 60-microgram dose level, the most common adverse events of any grade and irrespective of drug relationship were pyrexia (100%), lymphopenia (77%), leukopenia (69%), C-reactive protein increase (62%), and headache (69%) Most adverse events occurred early during treatment and improved or resolved during treatment. The most common grade 3 and 4 adverse event was lymphopenia (77%).

At active dose levels tested in this phase 1 clinical trial, permanent treatment discontinuation due to adverse events resulted mainly from fully reversible and transient neurological events during the first few days of treatment. A low ratio of B to T cells in peripheral blood was identified as a predictive biomarker for neurological events in patients with NHL. Based on these findings, and the possibility of adaptation of T cells by gradually increasing doses of blinatumomab, Micromet has developed a biomarker-guided dosing schedule designed to decrease the early neurological events and to provide all patients with the opportunity to reach the dose of 60 micrograms/squaremeter per day.

"We are very excited about the high response rate seen in patients with NHL treated at the 60-microgram dose level and are now planning larger studies to confirm these encouraging results," commented Dr. Jan Fagerberg, Micromet's Chief Medical Officer. "We expect that the biomarker-guided dosing schedule will accelerate the clinical development of blinatumomab in all relevant B-cell lymphoma indications."