Merck Serono, a division of Merck, Darmstadt, Germany, presented detailed results from the Phase III EXPAND* trial, at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria, September 28 – October 2, 2012. First results of this study were already announced in July 2012.
The results of the Phase III EXPAND trial showed that Erbitux® (cetuximab) in combination with capecitabine and cisplatin did not meet its primary endpoint, progression free survival, in patients with advanced gastric or gastro-esophageal junction cancer compared with chemotherapy alone.1 (HR 1.091, 95% CI 0.92-1.29; p = 0.316). The trial randomized 904 patients, to weekly Erbitux plus 3-week cycles of chemotherapy (n=455) or chemotherapy alone (n=449).1 The patients treated with Erbitux plus chemotherapy showed no new or unexpected safety findings and safety profiles were consistent with those known for the respective agents.1
“With few treatment choices and poor prognosis, these results are of course disappointing for patients and healthcare professionals alike. As a company we continue to invest in oncology research and development to find new treatments for diseases with such high unmet medical need,” said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for Merck Serono.
Importantly, the results do not alter the proven utility of Erbitux in its already approved indications in metastatic colorectal cancer and squamous cell carcinoma of the head and neck.
*EXPAND: Erbitux in combination with Xeloda and cisPlatin in AdvaNceD esophago-gastric cancer
1. Lordick F, et al. ESMO 2012 Congress; ESMO ID No: LBA3
For more information on Erbitux in colorectal and head & neck cancer, please visit: http://www.globalcancernews.com.
Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.
The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.
Erbitux has already obtained market authorization in 92 countries. It has been approved for the treatment of colorectal cancer in 92 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 89 countries.
Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.