– Early signs of activity observed in patients with diffuse large B-cell lymphoma
– Company plans to initiate a Phase 2 trial in mantle cell lymphoma in 2011
BETHESDA, MD, USA | December 6, 2010 | Micromet, Inc. (NASDAQ:MITI – News) today announced the presentation of updated results from an on-going Phase 1 trial of the Company’s lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin’s lymphoma (NHL). Results of the expanded experience suggest that blinatumomab continues to produce a high response rate and duration of response in a number of different NHL subtypes. Among patients who received the target dose of 60 micrograms per meter squared, 82% (18 of 22) achieved an objective response, including 4 out of 5 mantle cell lymphoma (MCL) patients. 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.
The data were reported in a poster presentation (abstract # 2880) yesterday at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.
“Blinatumomab continues to demonstrate a high objective response rate in heavily pre-treated non-Hodgkin’s lymphoma patients," said Andreas Viardot, M.D., University Hospital, Ulm, Germany. "Results of the expanded Phase 1 experience suggest that blinatumomab has the potential to alter the clinical course of disease in patients with a variety of NHL sub-types."
Phase 1 Study Design and Results
This multi-center Phase 1 study evaluates the safety and tolerability of blinatumomab in adult patients with relapsed non-Hodgkin’s lymphoma (NHL). The key objectives of the study are to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-lymphoma activity. Patient response is assessed using the Cheson criteria by independent radiologic review.
The data presented at ASH included 62 patients, mainly with diagnoses of mantle cell lymphoma (37%) and follicular lymphoma (FL) (39%). Most patients had received three or more prior lines of chemotherapy.
Investigators reported for the first time on the experience of patients with diffuse large B cell lymphoma. Notably, complete responses were observed in 3 of 6 patients treated.
"Blinatumomab demonstrates an attractive benefit risk profile in patients with mantle cell lymphoma that supports expanded development," said Christian Itin, Ph.D., Micromet’s President and Chief Executive Officer. “We will continue to explore blinatumomab’s potential utility in other NHL subtypes with a focus on DLBCL.”
The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant adverse events were fully reversible and manageable CNS events.
About Blinatumomab
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 Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is an aggressive form of non-Hodgkin’s lymphoma that comprises approximately 6% of all NHL cases1. It is one of the more difficult-to-treat types of lymphoma and often does not respond to chemotherapy. It is found in lymph nodes, the spleen, bone marrow, and gastrointestinal system. Mantle cell lymphoma usually develops in men over age 60.
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 BiTE® technology, as well as conventional monoclonal antibodies. The Company’s lead product candidate blinatumomab (MT103) is currently the subject of a 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 Bayer Schering Pharma, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and sanofi-aventis. Additional information can be found at www.micromet.com.
Reference:
1. Armitage et al. Non-Hodgkin’s Lymphoma Classification Project. JCO 1998
SOURCE: Micromet, Inc.
Post Views: 54
– Early signs of activity observed in patients with diffuse large B-cell lymphoma
– Company plans to initiate a Phase 2 trial in mantle cell lymphoma in 2011
BETHESDA, MD, USA | December 6, 2010 | Micromet, Inc. (NASDAQ:MITI – News) today announced the presentation of updated results from an on-going Phase 1 trial of the Company’s lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin’s lymphoma (NHL). Results of the expanded experience suggest that blinatumomab continues to produce a high response rate and duration of response in a number of different NHL subtypes. Among patients who received the target dose of 60 micrograms per meter squared, 82% (18 of 22) achieved an objective response, including 4 out of 5 mantle cell lymphoma (MCL) patients. 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.
The data were reported in a poster presentation (abstract # 2880) yesterday at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.
“Blinatumomab continues to demonstrate a high objective response rate in heavily pre-treated non-Hodgkin’s lymphoma patients," said Andreas Viardot, M.D., University Hospital, Ulm, Germany. "Results of the expanded Phase 1 experience suggest that blinatumomab has the potential to alter the clinical course of disease in patients with a variety of NHL sub-types."
Phase 1 Study Design and Results
This multi-center Phase 1 study evaluates the safety and tolerability of blinatumomab in adult patients with relapsed non-Hodgkin’s lymphoma (NHL). The key objectives of the study are to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-lymphoma activity. Patient response is assessed using the Cheson criteria by independent radiologic review.
The data presented at ASH included 62 patients, mainly with diagnoses of mantle cell lymphoma (37%) and follicular lymphoma (FL) (39%). Most patients had received three or more prior lines of chemotherapy.
Investigators reported for the first time on the experience of patients with diffuse large B cell lymphoma. Notably, complete responses were observed in 3 of 6 patients treated.
"Blinatumomab demonstrates an attractive benefit risk profile in patients with mantle cell lymphoma that supports expanded development," said Christian Itin, Ph.D., Micromet’s President and Chief Executive Officer. “We will continue to explore blinatumomab’s potential utility in other NHL subtypes with a focus on DLBCL.”
The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant adverse events were fully reversible and manageable CNS events.
About Blinatumomab
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 Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is an aggressive form of non-Hodgkin’s lymphoma that comprises approximately 6% of all NHL cases1. It is one of the more difficult-to-treat types of lymphoma and often does not respond to chemotherapy. It is found in lymph nodes, the spleen, bone marrow, and gastrointestinal system. Mantle cell lymphoma usually develops in men over age 60.
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 BiTE® technology, as well as conventional monoclonal antibodies. The Company’s lead product candidate blinatumomab (MT103) is currently the subject of a 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 Bayer Schering Pharma, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and sanofi-aventis. Additional information can be found at www.micromet.com.
Reference:
1. Armitage et al. Non-Hodgkin’s Lymphoma Classification Project. JCO 1998
SOURCE: Micromet, Inc.
Post Views: 54
