Micromet's Blinatumomab Achieves Primary Endpoint in Phase 2 Study with Acute Lymphoblastic Leukemia Patients
German Multicenter ALL Study Group Presented Data at the 14th Congress of the European Hematology Association Showing High Response Rate in Patients with Minimal Residual Disease
BERLIN, June 8 -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, announced that the German Multicenter ALL Study Group (GMALL) presented phase 2 clinical data of the BiTE(R) antibody blinatumomab (MT103) at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany, showing a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD)(1). Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells.
The patients included in this phase 2 clinical trial were in complete hematological remission following intense chemotherapy regimens, but retained a detectable level of ALL cancer cells in their bone marrow -- so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD.
The primary endpoint of the phase 2 study is MRD response within four cycles of treatment. MRD response is defined as the elimination of ALL cancer cells in patients with MRD below the limit of detection. The achievement of the primary endpoint requires that at least 22% of 21 patients have an MRD response. Currently, 13 of 16, or 81% of evaluated patients have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study. Patients in all subgroups responded to treatment with blinatumomab, including bcr-abl positive patients after failure of treatment with bcr-abl inhibitors, and patients with t(4;11) translocations. Side effects were observed primarily in the first 24 to 48 hours with transient pyrexia and lympho-/leukopenia being the most frequent adverse events.
"Blinatumomab is one of the most active agents the GMALL has tested in the adult ALL consolidation setting," said Dr. Ralf Bargou, principal investigator of the trial. "We are excited about the significant activity of blinatumomab in ALL and the favorable safety profile observed in this study. These results are particularly important for these patients who are in a disease stage with extremely poor prognosis and for which we lack treatment options except for patients eligible for allogenic stem cell transplantations."
"The ALL interim data showing an MRD response rate above 80% significantly exceeds the rate which was considered to be clinically meaningful and was set as the hurdle for the achievement of the primary end point," said Micromet's Senior Vice President and Chief Medical Officer, Carsten Reinhardt, M.D. "We are now looking forward to discussing a pivotal ALL program with the regulatory authorities later this year."
(1) Topp, M.S. et al (2009). Blinatumomab (anti-CD19 BiTE(R)) for targeted
therapy of minimal residual disease (MRD) in patients with B precursor
acute lymphoblastic leukemia (ALL): Update of an ongoing Phase II
study. 14th Congress of the EHA 2009, abstract no. 482
Micromet will host a webcast/conference call this morning from 9:00 am to 11:00 am U.S. Eastern time to discuss the blinatumomab data presented at the 14th Congress of the European Hematology Association. The webcast will be available on the company's website at www.micromet-inc.com. To participate in the conference call, dial 866-543-6403 (U.S.) or 617-213-8896 (international), passcode: 12594792.
A replay of the call will be available from 1:00 pm Eastern Time on June 8, 2009 (7:00 pm Central European Time) through June 15, 2009. The replay number is 888-286-8010 (U.S.) or 617-801-6888 (international), passcode: 67386852.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) antibody platform, as well as conventional monoclonal antibodies. BiTE antibodies represent a new class of antibodies that activate the T cells of a patient's immune system to eliminate cancer cells. Four of Micromet's antibodies are currently in clinical trials. Its BiTE antibody blinatumomab (MT103) is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia (ALL), and in a phase 1 clinical trial for the treatment of patients with non-Hodgkin's lymphoma (NHL). A second BiTE antibody, MT110, is in a phase 1 clinical trial for the treatment of patients with solid tumors. MT110 binds to the epithelial cell adhesion molecule, or EpCAM, which is overexpressed in many solid tumors. Micromet's human monoclonal antibody adecatumumab (MT201) also binds to EpCAM and is being developed under a collaboration with Merck Serono. Adecatumomab is in a phase 2 clinical trial in colorectal carcinoma patients after complete resection of liver metastases, and a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. Micromet's monoclonal antibody MT293, also known as TRC093, is licensed to TRACON Pharmaceuticals, Inc., and is in a phase 1 clinical trial for the treatment of patients with cancer.
In addition, Micromet has established a collaboration with Nycomed for the development and commercialization of MT203, a human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of various inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. Nycomed has filed a clinical trial application and is expected to commence a phase 1 clinical trial of MT203 in the first half of 2009. Micromet's licensee Morphotek, a wholly-owned subsidiary of Eisai, is also expected to initiate a first phase 1 clinical trial with Micromet's glycolipid-binding human antibody MT228 for the treatment of melanoma. Micromet also has entered into an option, collaboration and license agreement with Bayer Schering Pharma AG under which Bayer Schering Pharma was granted an exclusive option to license a specified BiTE antibody against an undisclosed solid tumor target.
Micromet's preclinical product pipeline includes several novel BiTE antibodies generated with its proprietary BiTE antibody platform technology. BiTE antibodies targeting CEA, MSCP, CD33, HER2, EGFR and other targets are in various stages of preclinical development.
This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the efficacy, safety and intended utilization of blinatumomab and other product candidates, the conduct, timing and results of future clinical trials, and expectations of the future expansion of our product pipeline and collaborations. You are urged to consider statements that include the words "ongoing," "may," "will," "believes," "potential," "expects," "plans," "anticipates," "intends," or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborators, including MedImmune, Merck Serono, TRACON and Nycomed, for the funding or conduct of further development and commercialization activities relating to our product candidates. These factors and others are more fully discussed in Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009, filed with the SEC on May 11, 2009, as well as other filings by the company with the SEC.