Interim data from Phase 1b Study indicate that adecatumumab in combination with docetaxel is safe and well tolerated and suggest a better outcome for breast cancer patients with high EpCAM expression
BETHESDA, MD, USA | September 15, 2008 | Micromet, Inc. (Nasdaq: MITI – News), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, presented interim data from a study investigating its anti-EpCAM antibody adecatumumab (MT201) in combination with the chemotherapeutic docetaxel(1) on Saturday, September 13 at the 2008 meeting of the European Society of Medical Oncology (ESMO) held in Stockholm, Sweden.
Adecatumumab is an antibody that targets EpCAM, a tumor antigen known to be associated with poor prognosis for many solid cancers. A previous phase 2 trial investigating adecatumumab as a single agent in patients with metastatic breast cancer (MBC) suggested that treatment with adecatumumab was associated with fewer new metastases in patients with high EpCAM expression compared to patients with low EpCAM expression(2).
The ongoing phase 1b clinical trial presented at ESMO investigated the safety and tolerability of increasing doses of adecatumumab in combination with standard chemotherapy docetaxel in relapsed MBC patients who had a median of three prior chemotherapy regimens. Combining adecatumumab with docetaxel appears to be feasible with clinically manageable diarrhea being the main toxicity at higher doses. Other frequently observed adverse events included nausea, vomiting, stomatitis, constipation, fatigue, fever and chills. No increase in adverse events or laboratory abnormalities typically seen with docetaxel was observed.
The overall response rate according to RECIST has been reported to be 43 percent in patients with high expression of EpCAM, the target of adecatumumab (3 of 7 patients), whereas no responses were detected in patients with low EpCAM expression (0 of 8 patients).
"These data demonstrate that adding adecatumumab to standard chemotherapy is feasible and suggest that the combination with taxanes could be a valuable treatment option for patients with high EpCAM expression," said Carsten Reinhardt, M.D., Ph.D., senior vice president and chief medical officer for Micromet. "The trend for a better outcome in patients with high EpCAM expression levels is in line with earlier observations and suggests a truly targeted effect of adecatumumab against EpCAM-positive tumor cells."
In addition to the continued clinical development in patients with breast cancer, Micromet is also in the process of setting up a randomized phase 2 clinical trial in patients suffering from colorectal cancer (CRC) after complete resection of first liver metastases.
(1) First results from a Phase 1b study of the anti-EpCAM antibody adecatumumab (MT201) in combination with docetaxel in patients with metastatic breast cancer. M. Schuler et al. ESMO Meeting Abstract, Sep 2008; Abstract 485P.
(2) Highly reduced incidence of new breast cancer metastases during treatment with adecatumumab appears to be the major factor for longer time to tumor progression in patients with high-level EpCAM expression Ch. Dittrich et al. AACR Meeting Abstract, Oct 2007; A71.
About ESMO
The European Society for Medical Oncology (ESMO) is the leading European non-profit professional organization for medical oncology, with a focus on promoting multidisciplinary cancer treatment around the world.
Since its founding in 1975, ESMO has continuously expanded its mission, aiming to create a wider community of people involved in the multifaceted aspects and phases of cancer: a community of professionals who share the common goal of providing optimal care to all cancer patients.
Through the years, the Society has strived to meet the needs of both oncologists and patients. For oncology professionals, ESMO serves and offers support to its members in their daily practice and careers by sharing knowledge and expertise through scientific and educational activities. For patients, ESMO partners with cancer patient associations and groups, by promoting direct and pro-active involvement of patients in educational, political, and networking activities. For the benefit of both, professionals and patients, in 2006 ESMO became active at the political level in order to influence issues which could impact the oncology community.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Four of its antibodies are currently in clinical trials, while the remainder of the product pipeline is in preclinical development. The BiTE® antibody blinatumomab (MT103/MEDI-538) is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia and in a phase 1 clinical trial for the treatment of patients with non-Hodgkin’s lymphoma. BiTE antibodies represent a new class of antibodies that activate a patient’s own cytotoxic T cells, considered the most powerful "killer cells" of the human immune system, to eliminate cancer cells. Micromet is developing blinatumomab in collaboration with MedImmune, Inc., a subsidiary of AstraZeneca plc. MT110 is the second BiTE antibody in clinical trials, and is being developed by Micromet in a phase 1 clinical trial for the treatment of patients with lung or gastrointestinal cancer. The third clinical stage antibody is adecatumumab, also known as MT201, a human monoclonal antibody that targets epithelial cell adhesion molecule (EpCAM)-expressing solid tumors. Micromet is developing adecatumumab in collaboration with Merck Serono in a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. The fourth clinical stage antibody is MT293 which is licensed to TRACON Pharmaceuticals, Inc. and is being developed in a phase 1 clinical trial for the treatment of patients with cancer. Three additional BiTE antibodies, targeting CD33, CEA and MCSP, respectively, are in preclinical development. 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.
SOURCE: Micromet, Inc.
Post Views: 91
Interim data from Phase 1b Study indicate that adecatumumab in combination with docetaxel is safe and well tolerated and suggest a better outcome for breast cancer patients with high EpCAM expression
BETHESDA, MD, USA | September 15, 2008 | Micromet, Inc. (Nasdaq: MITI – News), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, presented interim data from a study investigating its anti-EpCAM antibody adecatumumab (MT201) in combination with the chemotherapeutic docetaxel(1) on Saturday, September 13 at the 2008 meeting of the European Society of Medical Oncology (ESMO) held in Stockholm, Sweden.
Adecatumumab is an antibody that targets EpCAM, a tumor antigen known to be associated with poor prognosis for many solid cancers. A previous phase 2 trial investigating adecatumumab as a single agent in patients with metastatic breast cancer (MBC) suggested that treatment with adecatumumab was associated with fewer new metastases in patients with high EpCAM expression compared to patients with low EpCAM expression(2).
The ongoing phase 1b clinical trial presented at ESMO investigated the safety and tolerability of increasing doses of adecatumumab in combination with standard chemotherapy docetaxel in relapsed MBC patients who had a median of three prior chemotherapy regimens. Combining adecatumumab with docetaxel appears to be feasible with clinically manageable diarrhea being the main toxicity at higher doses. Other frequently observed adverse events included nausea, vomiting, stomatitis, constipation, fatigue, fever and chills. No increase in adverse events or laboratory abnormalities typically seen with docetaxel was observed.
The overall response rate according to RECIST has been reported to be 43 percent in patients with high expression of EpCAM, the target of adecatumumab (3 of 7 patients), whereas no responses were detected in patients with low EpCAM expression (0 of 8 patients).
"These data demonstrate that adding adecatumumab to standard chemotherapy is feasible and suggest that the combination with taxanes could be a valuable treatment option for patients with high EpCAM expression," said Carsten Reinhardt, M.D., Ph.D., senior vice president and chief medical officer for Micromet. "The trend for a better outcome in patients with high EpCAM expression levels is in line with earlier observations and suggests a truly targeted effect of adecatumumab against EpCAM-positive tumor cells."
In addition to the continued clinical development in patients with breast cancer, Micromet is also in the process of setting up a randomized phase 2 clinical trial in patients suffering from colorectal cancer (CRC) after complete resection of first liver metastases.
(1) First results from a Phase 1b study of the anti-EpCAM antibody adecatumumab (MT201) in combination with docetaxel in patients with metastatic breast cancer. M. Schuler et al. ESMO Meeting Abstract, Sep 2008; Abstract 485P.
(2) Highly reduced incidence of new breast cancer metastases during treatment with adecatumumab appears to be the major factor for longer time to tumor progression in patients with high-level EpCAM expression Ch. Dittrich et al. AACR Meeting Abstract, Oct 2007; A71.
About ESMO
The European Society for Medical Oncology (ESMO) is the leading European non-profit professional organization for medical oncology, with a focus on promoting multidisciplinary cancer treatment around the world.
Since its founding in 1975, ESMO has continuously expanded its mission, aiming to create a wider community of people involved in the multifaceted aspects and phases of cancer: a community of professionals who share the common goal of providing optimal care to all cancer patients.
Through the years, the Society has strived to meet the needs of both oncologists and patients. For oncology professionals, ESMO serves and offers support to its members in their daily practice and careers by sharing knowledge and expertise through scientific and educational activities. For patients, ESMO partners with cancer patient associations and groups, by promoting direct and pro-active involvement of patients in educational, political, and networking activities. For the benefit of both, professionals and patients, in 2006 ESMO became active at the political level in order to influence issues which could impact the oncology community.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Four of its antibodies are currently in clinical trials, while the remainder of the product pipeline is in preclinical development. The BiTE® antibody blinatumomab (MT103/MEDI-538) is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia and in a phase 1 clinical trial for the treatment of patients with non-Hodgkin’s lymphoma. BiTE antibodies represent a new class of antibodies that activate a patient’s own cytotoxic T cells, considered the most powerful "killer cells" of the human immune system, to eliminate cancer cells. Micromet is developing blinatumomab in collaboration with MedImmune, Inc., a subsidiary of AstraZeneca plc. MT110 is the second BiTE antibody in clinical trials, and is being developed by Micromet in a phase 1 clinical trial for the treatment of patients with lung or gastrointestinal cancer. The third clinical stage antibody is adecatumumab, also known as MT201, a human monoclonal antibody that targets epithelial cell adhesion molecule (EpCAM)-expressing solid tumors. Micromet is developing adecatumumab in collaboration with Merck Serono in a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. The fourth clinical stage antibody is MT293 which is licensed to TRACON Pharmaceuticals, Inc. and is being developed in a phase 1 clinical trial for the treatment of patients with cancer. Three additional BiTE antibodies, targeting CD33, CEA and MCSP, respectively, are in preclinical development. 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.
SOURCE: Micromet, Inc.
Post Views: 91
