Public HealthMicromet Presents Update At ASCO 2009 On A Phase 1b Combination Study Of Adecatumumab And Docetaxel
Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, presented data from a clinical trial investigating its anti-EpCAM human antibody adecatumumab (MT201) in combination with the chemotherapeutic docetaxel in patients with metastatic breast cancer (MBC) at the annual meeting of the American Society of Clinical Oncology (ASCO) held in Orlando, Florida, USA(1).
The phase 1b clinical trial presented at ASCO investigates the safety and tolerability of increasing doses of adecatumumab given every 3 weeks in combination with standard chemotherapy docetaxel (Taxotere(R)) in relapsed MBC patients who had a median of three prior chemotherapy regimens (n=22 assessable for safety and n=19 evaluable for efficacy). Adecatumumab is an antibody that targets EpCAM, a tumor antigen known to be associated with poor prognosis for breast cancer patients. Combining adecatumumab with docetaxel was 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. Laboratory abnormalities included reduction in various blood cells such as lymphocytes and neutrophils comparable to what is typically observed with docetaxel monotherapy.
The overall response rate according to RECIST [version 1.0] was 38% in patients with high expression of EpCAM (n=8), the target of adecatumumab, compared to 9% in patients with low EpCAM expression (n=11). Patients treated with higher doses of adecatumumab also appeared to have a longer time to progression when compared to patients treated at lower doses (167 days versus 83 days). These observations are in line with data from a previous phase 2 trial investigating adecatumumab as a single agent in MBC patients that also suggested that treatment with adecatumumab was associated with better outcome in patients with high EpCAM expression compared to patients with low EpCAM expression(2). Micromet is currently also conducting a randomized phase 2 clinical trial with adecatumumab in patients with colorectal cancer after complete resection of liver metastases.
"These data indicate that adding adecatumumab to standard chemotherapy is feasible," said Carsten Reinhardt, M.D., Ph.D., senior vice president and chief medical officer of Micromet. "The combination of adecatumumab with taxanes could be a valuable development option for MBC patients with high EpCAM expression on their tumors, and would offer an antibody-based therapy to those patients who express EpCAM but not Her-2 and thus do not qualify for Her-2-targeting antibody therapy."
(1) Sebastian, M. et al. (2009). Safety and anti-tumor activity of 3-weekly anti-EpCAM antibody adecatumumab (MT201) in combination with docetaxel for patients with metastatic breast cancer: Results of a multicenter phase Ib trial. ASCO meeting abstract no. 1009.
(2) Schmidt, M. et al. (2009). An open-label, randomized phase II study of adecatumumab, a fully human anti-EpCAM antibody, as monotherapy in patients with metastatic breast cancer. Annals of Oncology, in press.
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, a division of Merck KGaA of Darmstadt, Germany. Adecatumumab 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.
Forward-Looking Statements
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 adecatumumab 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.
Micromet, Inc