Merck KGaA says that the first patient has been enrolled into a Phase III study which will assess Erbitux in combination with two chemotherapies as a treatment for gastric cancer.

The EXPAND study will look at Erbitux (cetuximab) in combination with cisplatin and capecitabine as a first-line treatment for patients with advanced/metastatic gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma. The primary endpoint of the trial, which will recruit approximately 870 patients at 150 centres in 25 countries, 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 Florian Lordick of the University of Heidelberg and lead investigator of EXPAND. The firm noted that gastric cancer is notoriously difficult to treat and is associated with a poor prognosis. Surgery is potentially curative but the majority of patients present with late-stage disease and are therefore candidates for palliative chemotherapy only, it added.

This pivotal trial follows three successful Phase II studies in first-line gastric cancer and is "another step in the development of Erbitux in this treatment area,” said 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", he added.

Erbitux has so far has been approved in over 65 countries for bowel tumours when other treatments have failed, and for head and neck cancer. Merck, the European licensee for the drug which was discovered by ImClone and is sold in the USA with partner Bristol-Myers Squibb, expects to file for approval for the gastric cancer indication in 2011