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news.Merck KGaA has announced that the first patient has been enrolled into its pivotal Phase III gastric cancer clinical study, Expand. Expand is a multi-center, open-label, controlled study that will recruit approximately 870 patients at 150 centers in 25 countries worldwide.
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The study by the Merck Serono division will assess the clinical benefit of the targeted cancer therapy Erbitux (cetuximab) in combination with cisplatin and capecitabine as a first-line treatment for patients with advanced/metastatic gastric adenocarcinoma including gastroesophageal junction adenocarcinoma. The primary endpoint of the study is progression-free survival.
Erbitux is a monoclonal antibody already approved for the treatment of colorectal and head and neck cancers and is said to be the first targeted therapy to show a significant survival benefit in first-line non-small-cell lung cancer in patients across all histological subtypes.
Wolfgang Wein, executive vice president for Merck Serono’s global oncology unit, said: “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.”