Date: 2012-07-05
Type of information: Results
phase: 3
Announcement: results
Company: Merck Serono, a Merck KGaA company (Germany)
Product: Erbitux® (cetuximab)
Action
mechanism: Erbitux® is a first-in-class 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.
Disease: advanced gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction (GEJ)
Therapeutic area: Cancer - Oncology
Country: Latin America, Europe, Asia Pacific and Japan
Trial
details: EXPAND (Erbitux in combination with Xeloda and cisPlatin in AdvaNceD esophagogastric cancer) was a multi-center, open-label, randomized, controlled trial in 904 patients at 150 centers in 25 countries across Latin America, Europe, Asia Pacific and Japan. Patients had unresectable advanced cancer of the stomach or GEJ and had received no prior treatment with chemotherapy or radiotherapy in this setting. Usually, these patients would receive palliative chemotherapy only. The study’s primary endpoint was PFS as determined by an independent review committee (IRC). Secondary endpoints were overall survival (OS), best overall response rate determined by IRC, safety and quality of life.
Latest
news: Merck KGaA has announced the outcome of the Phase III clinical trial EXPAND, which assessed Erbitux® (cetuximab) in combination with cisplatin and capecitabine as a first-line treatment for patients with advanced gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction (GEJ). The trial did not meet its primary endpoint of extending the length of time that patients live without their disease getting worse (progression-free survival – PFS), as determined by independent review. Erbitux® in combination with cisplatin and capecitabine did not show any new or unexpected safety findings. More detailed results from the trial will be submitted for presentation at upcoming international scientific meetings.
