Micromet Presents Update at ASCO 2009 on a Phase 1b Combination Study of Adecatumumab and Docetaxel
June 01 2009 - 7:00AM
PR Newswire (US)
Data indicate target-dependent activity in breast cancer patients
with high expression of EpCAM ORLANDO, Fla., June 1
/PRNewswire-FirstCall/ -- 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.
DATASOURCE: Micromet, Inc. CONTACT: US Media: Andrea tenBroek or
Chris Stamm, +1-781-684-0770, ; or for European Media: Ludger Wess,
+49-(40)-8816-5964, ; or for US Investors: Susan Noonan,
+1-212-966-3650, ; or for European Investors: Ines-Regina Buth,
+49-(30)-2363-2768, , all for Micromet, Inc. Web Site:
http://www.micromet-inc.com/
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