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Home Industry News Merck KGaA begins phase III Erbitux study

Merck KGaA begins phase III Erbitux study

10th July 2008

Merck KGaA has announced the initiation of a pivotal phase III study of Erbitux (cetuximab) used in combination with Xeloda (capecitabine) and cisplatin in advanced esophago-gastric cancer.

The Merck Serono division of the company has begun patient enrolment in the Expand study which will assess the clinical benefit of the therapy as a first-line treatment for advanced or mestastatic gastric adenocarcinoma patients, including gastroesophageal junction adenocarcinoma.

Merck notes the primary endpoint of the trial is progression-free survival.

Erbitux is a monoclonal antibody approved as a treatment for colorectal and head and neck cancers.

It is the first targeted therapy that has shown significant survival benefit as a first-line treatment for non-small cell lung cancer in all histological subtypes.

Dr Wolfgang Wein, executive vice-president for the global oncology unit of Merck Serono, said: “Recruitment into this pivotal trial follows three successful Phase II studies in first-line gastric cancer.

“The Expand study is another step in the development of Erbitux in this treatment area.”

He added that the combining of novel targeted agents such as Erbitux with standard chemotherapy regimens is the foundation of the firm’s dedication to oncology and vital to the provision of more effective cancer treatments.

In October 2007, Merck KGaA announced an agreement for the co-development and co-commercialisation of Erbitux in Japan with ImClone Systems and Bristol-Myers Squibb.

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