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Merck KGaA reports disappointing results for Erbitux in Phase III colon cancer trial

Wednesday, May 09 2012 | Comments
Evidence Grade 0 What's This?
Merck KGaA reported that results of an interim analysis of the European PETACC-8 study failed to show improvement in disease-free survival when Erbitux (cetuximab) was added to standard chemotherapy for the adjuvant treatment of colon cancer in patients with KRAS wild-type tumors.

The Phase III trial included 2,559 patients with stage III colon cancer that had been fully resected, including 1,602 patients with KRAS wild-type tumors. The participants were randomized to receive Erbitux plus FOLFOX4 chemotherapy or FOLFOX4 alone for six months. The primary endpoint of the trial is disease-free survival.

The prespecified interim analysis was conducted after a median of 3.3 years of follow-up.

"Unfortunately, since the introduction of FOLFOX as standard treatment, all attempts to further improve prevention of disease recurrence have proved unsuccessful," said Dr. Julien Taieb, principal investigator of the trial.

"While these results are disappointing, we continue to invest in expanding the science behind Erbitux to ensure its appropriate and safe use for patients living with cancer," said Dr. Annalisa Jenkins, head of global drug development and medical for Merck's Merck Serono division.

Bristol-Myers Squibb Co. (BMS) and ImClone LLC, a wholly owned subsidiary of Eli Lilly and Co., market Erbitux, an epidermal growth factor receptor (EGFR)-targeted monoclonal antibody, in the United States. Merck licensed the rights to Erbitux outside the United States and Canada from ImClone in 1998. In Japan, ImClone, BMS and Merck jointly develop and market Erbitux.

In the United States, Erbitux is approved, alone or in combination with chemotherapy, for the treatment of patients who have colorectal cancer that has spread to other parts of the body and whose tumor expresses EGFR. The drug is also approved to treat nonmetastatic, squamous cell carcinoma of the head and neck in combination with radiation therapy (first-line) or as a single agent in patients with this type of cancer whose tumor has returned in the same location or has metastasized and whose disease has progressed following standard treatment. In addition, last November, the Food and Drug Administration approved Erbitux for use with chemotherapy for patients with metastatic head and neck cancer.

This information may concern a use that has not been approved by the FDA.

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