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Home / International News / Press Releases / 2010 / October / October 4, 2010
New Data for Erbitux in Prevalent Cancers to Be Revealed at ESMO
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New Data for Erbitux in Prevalent Cancers to Be Revealed at ESMO

Milan, Italy and Darmstadt, Germany

ESMO Abstract Numbers: 274O, 882P, 596P, 1031P, 1033P

Merck Serono, a division of Merck KGaA, Darmstadt, Germany announces today that it will be presenting new data from several studies of Erbitux® (cetuximab) in a range of solid tumor types – including the first Phase II data in breast and prostate cancers. These data will be presented at the forthcoming 35th European Society for Medical Oncology Congress (ESMO) in Milan, October 8-12, 2010.

New data in breast cancer and prostate cancer
The first data from a randomized Phase II study of Erbitux in triple negative breast cancer (TNBC) will be presented during the ESMO Congress. TNBC does not express receptors for estrogen, progesterone or HER2 and does thus not respond to hormone or anti-HER2 therapy. Although TNBC can be treated with chemotherapy, early relapse and metastasis are common. These new data for Erbitux are therefore particularly relevant as TNBC represents a significant threat to women with this type of cancer, for whom there are few treatment options or hopes for cure.

In addition, new data for Erbitux in prostate cancer will be presented for the first time at the ESMO Congress. Experts predict a greater than 13% rise in the number of cases of the disease diagnosed this year compared to 20091 reinforcing a clear and urgent need for effective new treatments.

In addition to this promising data for Erbitux in novel indications, Merck Serono will also present new results from key studies of Erbitux in existing treatment areas:

Metastatic colorectal cancer
Latest findings from the renowned Phase III CRYSTAL study, which established the value of the KRAS biomarker in metastatic colorectal cancer (mCRC), will be presented. The personalized therapy model has revolutionized cancer management. Merck Serono has been a driving force behind this dynamic shift in the mCRC treatment approach with its groundbreaking data from multiple Erbitux studies.

Head and neck cancer
Recent developments in squamous cell carcinoma of the head and neck (SCCHN) have generated a paradigm shift in treatment of this disease. Data from two key surveys will quantify the role of Erbitux in the treatment of SCCHN. Erbitux is the only proven targeted therapy and – as combination treatment – a standard of care for patients with locally advanced and 1st line recurrent metastatic SCCHN.
Merck Serono is committed to developing quality resources to provide the latest information on developments in oncology. Before and during the ESMO Congress will provide information and opportunities to keep media informed about the latest data and expert opinions coming from the event. Registration takes less than a minute and visitors to the site will be able to:


1 Andriole GL et al. NEJM 2009;360:13

About Erbitux

Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in 80 countries. It has been approved for the treatment of colorectal cancer in 80 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 77 countries:

Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.

Merck is also investigating among other potential cancer treatments the use of Stimuvax® (BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA.

In addition, Merck is developing cilengitide, which is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its vasculature.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of more than 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

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Source:Business Wire (Business Wire India)

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