Merck KGaA (MKGAY.PK) said its cancer drug Erbitux failed to meet primary goal of progression-free survival in a late-stage trial in patients with advanced gastric cancer.
Erbitux is already approved to be used alone or with other drugs to treat colorectal cancer and certain head and neck cancers. The German pharmaceuticals firm noted that the latest results do not alter these properties of the drug.
The phase 3 clinical trial, dubbed EXPAND, assessed Erbitux in combination with standard chemotherapy drugs cisplatin and capecitabine as a first-line treatment for patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastro-esophageal junction.
Lead investigator Florian Lordick said, "We are disappointed that the EXPAND trial did not show a benefit for patients with advanced gastric cancer when Erbitux was added to standard chemotherapy."
Merck KGaA has licensed the right to market Erbitux (cetuximab) outside the US and Canada from ImClone LLC - a unit of Eli Lilly and Co. (LLY).
The trial was a multi-center, open-label, randomized, controlled study in 904 patients at 150 centers in 25 countries across Latin America, Europe, Asia Pacific and Japan.
The results showed that the drug did not significantly increase the length of time that patients live without their disease getting worse. Secondary endpoints in the study were overall survival, best overall response rate determined by IRC, safety and quality of life.
Gastric cancer, commonly called stomach cancer, is the second most common cause of cancer-related deaths and the fourth most commonly diagnosed cancer after lung, breast and colorectal cancers.
Erbitux has already obtained marketing authorization in 92 countries for treating colorectal cancer and in 89 countries for treating squamous cell carcinoma of the head and neck.
In the first quarter of fiscal 2012, Merck KGaA's sales of the targeted cancer treatment Erbitux increased 1.3 percent on an organic basis to 214 million euros.
Annalisa Jenkins of Merck Serono division said, "Understandably, these results are disappointing for patients with advanced gastric cancer, and as a company we will continue to invest in oncology research and development to find new treatments for these diseases with high unmet medical need."
The company will submit for presentation more detailed results from the trial at upcoming international scientific meetings.
On Frankfurt's Xetra, Merck shares are currently trading at 78.31 euros, down 1.64 euros or 2.05 percent.
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by RTT Staff Writer
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