Merck Serono: Erbitux(R) Phase III Clinical Study In Gastric Cancer Started

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 10 Jul 2008 - 3:00 PDT

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Merck Serono, a division of Merck KGaA, announced that the first patient has been enrolled into its pivotal Phase III gastric cancer clinical study, EXPAND (Erbitux in combination with Xeloda and cisplatin in advanced esophago-gastric cancer). The study will assess the clinical benefit of the targeted cancer therapy Erbitux® (cetuximab) in combination with cisplatin and capecitabine as a 1st-line treatment for patients with advanced/metastatic gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma. The primary endpoint of the study is progression-free survival.

"The start of the EXPAND study is very exciting because there is a real unmet medical need in this treatment area," said Dr Florian Lordick, National Center for Tumor Diseases University of Heidelberg, Germany, Lead Investigator for the EXPAND study.

Gastric cancer, also known as stomach cancer, is notoriously difficult to treat and is associated with a poor prognosis. In resectable gastric cancer, surgery is potentially curative, but the majority of patients present with late stage disease and are therefore candidates for palliative chemotherapy only.

"Recruitment into this pivotal trial follows three successful Phase II studies in 1st-line gastric cancer. The EXPAND study is another step in the development of Erbitux in this treatment area," said Dr. Wolfgang Wein, Executive Vice President for Merck Serono's Global Oncology Unit. "Combining standard chemotherapy regimens with innovative targeted agents, such as Erbitux, is key to providing more effective cancer treatments and underpins Merck Serono's commitment to oncology."

Erbitux is a monoclonal antibody (MAb) already approved for the treatment of colorectal and head and neck cancers and has also demonstrated as the first targeted therapy to show a significant survival benefit in 1st-line non-small-cell lung cancer in patients across all histological subtypes.1 Like the antibodies circulating as part of the immune system, Erbitux identifies and locks on to a specific target - in this case, the epidermal growth factor receptor (EGFR), which is expressed in certain cancers, including gastric cancer.

Gastric cancer is the second leading cause of cancer death in men and the fourth among women worldwide. Generally, gastric cancer rates are about twice as high in men as in women.2 Each year nearly 930,000 people worldwide are diagnosed with gastric cancer and approximately 700,000 die of the disease.3

EXPAND is a multi-center, open-label, controlled study that will recruit approximately 870 patients at 150 centers in 25 countries worldwide.

References

1. Pirker R, et al. ASCO 2008;Abstract No: 3.
2. American Cancer Society publication, Cancer Facts & Figures, 2007.
3. Parkin DM et al. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: http://www.globalcancernews.com.

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 72 countries. It has been approved for the treatment of colorectal cancer in 71 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, the European Union, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Liechtenstein, Malaysia, Mexico, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Lebanon, Mexico, New Zealand, Nicaragua, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.

In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 65 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Liechtenstein, Malaysia, Mexico, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Nicaragua, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, ImClone Systems Incorporated, Bristol-Myers Squibb Company and Merck jointly develop and, upon approval, 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 cancer treatments the use of Stimuvax® (formerly referred to as 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., Bellevue, Washington, USA.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).

With an annual R&D investment of around € 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.

For more information, please visit http://www.merckserono.net or http://www.merck.de

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,681 employees in 60 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.

http://www.merck.de

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