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 Tumour 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. 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. Each year nearly 930,000 people worldwide are diagnosed with gastric cancer and approximately 700,000 die of the disease.

Expand is a multi-centre, open-label, controlled study that will recruit approximately 870 patients at 150 centres in 25 countries worldwide.

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 tumour cells and the spread of tumours to new sites. It is also believed to inhibit the ability of tumour cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumours, which appears to lead to an overall suppression of tumour growth.