Updated Results from Phase 2 Trial Demonstrate Prolonged Hematologic Relapse-Free Survival of Micromet's Blinatumomab in Patients with Acute Lymphoblastic Leukemia
BETHESDA, Md., June 14 Micromet, Inc. (Nasdaq: MITI) today announced the presentation of updated results from a Phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). Results of the analysis demonstrate that a prolonged hematologic relapse free survival was observed in patients treated with blinatumomab. As of April 2010, six of nine evaluable, MRD responding, non-transplanted patients were in hematologic remission, ranging up to 23 months. Historical experience suggests that the majority of patients with MRD following front-line chemotherapy who do not receive a transplant will relapse within one year. Blinatumomab is the first of a new class of agents called BiTEŽ antibodies, designed to harness the body's T cells to kill cancer cells.
Dr. Max Topp, Department of Internal Medicine II, University of Wuerzburg presented the study findings on June 12, 2010 in an oral presentation (abstract # 0598) at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.
"Adult acute lymphoblastic leukemia is a difficult to treat disease that has seen no meaningful improvement in decades," said Dr. Topp. "These data clearly demonstrate that blinatumomab has the potential to fundamentally change the outcome for patients with ALL."
Phase 2 Study Design
This multi-center Phase 2 study evaluated the efficacy and safety of blinatumomab in adult 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 observed in the eight patients who received blinatumomab and then underwent a transplant. This highlights the potential for blinatumomab to provide an opportunity to arrange a transplant, and potentially to improve the outcome of the transplant by safely reducing the burden of leukemia before transplant."
"These data continue to validate our confidence in blinatumomab's potential as a promising new treatment option for patients with ALL and heighten our excitement in the pivotal trial we are on track to begin in the third quarter," said Christian Itin, Ph.D, Micromet's President and Chief Executive Officer.
Pivotal Trial in ALL
Based on the results reported to date in ALL, Micromet plans to initiate a pivotal, non-randomized, multi-center trial intended to confirm the efficacy and safety of blinatumomab in adult patients with B precursor ALL with minimal residual disease after treatment with front-line chemotherapy. Patients will receive 15 micrograms per meter squared per day of blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle. The primary endpoint of the study is MRD response as assessed by PCR analysis. The key secondary endpoint is time to hematological relapse (for non-transplanted patients). The Company currently plans to enroll up to 130 evaluable patients at approximately 70 leading cancer centers in Europe and the U.S.
Conference Call and Webcast
Micromet management will host a conference call on Tuesday, June 15 at 8:30 AM EDT to review the data presented at EHA. To participate in the conference call, please dial 866-770-7120 (domestic) or 617-213-8065 (international) and reference the access code 28465583. The presentation will be available via webcast at:
A replay of the call will be available from 11:30 AM ET on June 15, 2010 until midnight on June 22, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 87529369. The archived webcast will be available for 30 days in the Investor Relations section of the Micromet website at www.micromet-inc.com.
Blinatumomab (MT103) is a novel, 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 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 Food and Drug Association for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia, indolent B cell lymphoma, hairy cell leukemia and prolymphocytic leukemia.
About Acute Lymphoblastic Leukemia
Acute Lymphocytic Leukemia (ALL) is a cancer of the blood and bone marrow that afflicts 5,760 patients in the U.S. annually(2). The average five-year survival rate for adult ALL patients after 1st relapse is 7%. The presence of minimal residual disease, or MRD, is a recognized negative prognostic factor for patients with ALL. According to published results(3), MRD-negative patients incurred a 6% risk of relapse compared to an 89% risk in patients remaining MRD positive after chemotherapy. There are currently no therapies approved for the treatment of MRD-positive ALL.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTEŽ technology, as well as conventional monoclonal antibodies. Two of Micromet's BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including sanofi-aventis, Bayer Schering Pharma, Merck Serono, Boehringer Ingelheim, MedImmune and Nycomed. Additional information can be found at www.micromet-inc.com
This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially 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 and its use in the treatment of cancer. 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 our preclinical data is not confirmed in clinical trials with our product candidates. This factor and others are more fully discussed in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2010. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
1. Nicola Goekbuget, M.D. remarks, Micromet R&D Day, February 2010
2. American Cancer Society. Cancer Facts and Figures 2009.
3. Raff et al. Molecular relapse in adult standard-risk ALL patients detected by prospective MRD monitoring during and after maintenance treatment. Blood. 2007109: 910-915
SOURCE Micromet, Inc.
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