ROCKVILLE, Md.--(BUSINESS WIRE)-- Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.
"Relapsed/refractory acute lymphoblastic leukemia is a difficult to treat disease that has seen no meaningful improvement in decades," said Professor Max Topp, Department of Internal Medicine II, University of Wuerzburg and the study’s coordinating investigator for Europe. "To date blinatumomab has demonstrated an unprecedented level of efficacy and adequate safety in a patient population with limited therapeutic options."
This phase 2, single-arm study will evaluate the efficacy and safety of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL. Patients will receive blinatumomab daily for 28 days followed by two weeks off blinatumomab over a six week treatment cycle. Patients who achieve a complete remission (CR) or complete response without full recovery of platelets (CRh*) within two cycles of treatment will receive up to three additional cycles of consolidation treatment. The primary endpoint of the study is CR/CRh*. Secondary endpoints include duration of response and overall survival. The study will be conducted at approximately 40 leading cancer centers in the U.S. and EU. The Company currently expects to complete enrollment in this trial by year end 2012.
“In the event that initial data generated from this trial are compelling, we plan to discuss with the FDA potential avenues to accelerate blinatumomab’s path to market,” said Jan Fagerberg, MD, Ph.D., Micromet’s Senior Vice President and Chief Medical Officer.
Additional information regarding this Phase 2 study is available at the U.S. government's clinical trials database at http://www.clinicaltrials.gov.
Blinatumomab Clinical Experience in Adult R/R ALL
Interim results from a Phase 2 trial presented at the 2011 Meeting of the European Hematology Association show that blinatumomab produced a high CR rate in adult patients with ALL who had relapsed following treatment with standard therapy. 75% of patients (9 of 12) achieved a CR or CRh* following treatment with blinatumomab1. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*. The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable central nervous system (CNS) events.
Blinatumomab (MT103) is a next-generation monoclonal antibody designed to direct the body's cell destroying T-cells against CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non Hodgkin's lymphomas.
Micromet has received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the U.S. Food and Drug Administration for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia and indolent B cell lymphoma.
About Relapsed/Refractory Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia (ALL) is an aggressive cancer of the blood and bone marrow that afflicts 5,330 patients in the U.S. annually2. Patients with ALL have abnormal white blood cells (lymphocytes) that crowd out healthy white and red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and other serious effects. 50%−60%5,9 of patients will relapse following frontline therapy. 15 - 20%9 of patients have refractory disease, defined as failure to respond to frontline therapy. With current approaches used to treat r/r ALL, complete remission rates typically range from 20 - 30%3-6. Standard chemotherapy is associated with a mortality rate of up to 23%8. The average five-year survival rate for adult ALL patients after first relapse is 7%6.
About Micromet, Inc.
Micromet is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. The Company is advancing a robust pipeline of novel therapeutics based on its proprietary BiTE® technology. The Company's lead product candidate blinatumomab (MT103) is currently the subject of a European pivotal trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Amgen, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, MedImmune, Nycomed and Sanofi. For additional information, please visit www.micromet.com
Safe Harbor Statement
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 development of blinatumomab, including the conduct and timing of ongoing and future clinical trials involving blinatumomab, the number of patients, the location of clinical trial sites, the timing of the enrollment of patients and the reporting of date from the recently initiated phase 2 clinical trial, the plans for discussions with the FDA regarding the development path for bliatumomab, the plans for future clinical trials and potential safety, efficacy and utility of blinatumomab, and the potential impact on the long-term survival of ALL patients treated with blinatumomab. You are urged to consider statements that include the words “expects,” "continues," "will," "believes," "potential," "plans," "intends," “may,” “suggests” 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 blinatumomab does not demonstrate safety and/or efficacy in future clinical trials, delays in development and testing, including the risk that we will not obtain approval to market blinatumomab, and the risks associated with reliance on collaboration partners and outside financing to meet capital requirements. These factors and others are more fully discussed in Micromet's Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2010, and Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2011, filed with the SEC on November 8, 2011 as well as other filings by Micromet with the SEC.
1. Topp, M.S. et. al. Haematologica. 2011; abstract no. 844
2. National Cancer Institute, 2010 SEER ALL incidence data
3. Kantarjian H, et al. Cancer. 2010;116:5568-5574.
4. Advani AS, et al. Br J Haematol. 2010;151(5):430.
5. Oriol A, et al. Haematologica. 2010;98(4):589-596.
6. Fielding A, et al. Blood. 2007;109(3):944-950.
7. O'Brien S, et al. Cancer. 2008;113:3186-3191.
8. Bassan R, et al. J Clin Oncol. 2011;29(5):532-543
9. Annino L, et al. Blood. 2002;99:863-871.
Jennifer Neiman, 240-235-0246
Director, Corporate Communications
KEYWORDS: United States North America Maryland
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical Research Science