BETHESDA, Md., Sept. 15 Micromet, Inc.(Nasdaq: MITI), a biopharmaceutical company developing novel, proprietaryantibodies for the treatment of cancer, inflammation and autoimmune diseases,presented interim data from a study investigating its anti-EpCAM antibodyadecatumumab (MT201) in combination with the chemotherapeutic docetaxel(1) onSaturday, September 13 at the 2008 meeting of the European Society of MedicalOncology (ESMO) held in Stockholm, Sweden.
Adecatumumab is an antibody that targets EpCAM, a tumor antigen known tobe associated with poor prognosis for many solid cancers. A previous phase 2trial investigating adecatumumab as a single agent in patients with metastaticbreast cancer (MBC) suggested that treatment with adecatumumab was associatedwith fewer new metastases in patients with high EpCAM expression compared topatients with low EpCAM expression(2).
The ongoing phase 1b clinical trial presented at ESMO investigated thesafety and tolerability of increasing doses of adecatumumab in combinationwith standard chemotherapy docetaxel in relapsed MBC patients who had a medianof three prior chemotherapy regimens. Combining adecatumumab with docetaxelappears to be feasible with clinically manageable diarrhea being the maintoxicity at higher doses. Other frequently observed adverse events includednausea, vomiting, stomatitis, constipation, fatigue, fever and chills. Noincrease in adverse events or laboratory abnormalities typically seen withdocetaxel was observed.
The overall response rate according to RECIST has been reported to be 43percent in patients with high expression of EpCAM, the target of adecatumumab(3 of 7 patients), whereas no responses were detected in patients with lowEpCAM expression (0 of 8 patients).
"These data demonstrate that adding adecatumumab to standard chemotherapyis feasible and suggest that the combination with taxanes could be a valuabletreatment option for patients with high EpCAM expression," said CarstenReinhardt, M.D., Ph.D., senior vice president and chief medical officer forMicromet. "The trend for a better outcome in patients with high EpCAMexpression levels is in line with earlier observations and suggests a trulytargeted effect of adecatumumab against EpCAM-positive tumor cells."
In addition to the continued clinical development in patients with breastcancer, Micromet is also in the process of setting up a randomized phase 2clinical trial in patients suffering from colorectal cancer (CRC) aftercomplete resection of first liver metastases.
(1) First results from a Phase 1b study of the anti-EpCAM antibodyadecatumumab (MT201) in combination with docetaxel in patients with metastaticbreast cancer. M. Schuler et al. ESMO Meeting Abstract, Sep 2008; Abstract485P.
(2) Highly reduced incidence of new breast cancer metastases duringtreatment with adecatumumab appears to be the major factor for longer time totumor progression in patients with high-level EpCAM expression Ch. Dittrich etal. AACR Meeting Abstract, Oct 2007; A71.
The European Society for Medical Oncology (ESMO) is the leading Europeannon-profit professional organization for medical oncology, with a focus onpromoting 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 multifacetedaspects and phases of cancer: a community of professionals who share thecommon goal of providing optimal care to all cancer patients.
Through the years, the Society has strived to meet the needs of bothoncologists and patients. For oncology professionals, ESMO serves and offerssupport to its members in their daily practice and careers by sharingknowledge and expertise through scientific and educational activities. Forpatients, ESMO partners with cancer patient as