Merck KGaA's Erbitux combined with radio therapy improves survival rate in SCCHN trials

Germany's Merck KGaA says that research, published in the New England Journal of Medicine shows that its monoclonal antibody Erbitux (cetuximab) confers a significant survival advantage in patients with locally-advanced squamous cell carcinoma of the head and neck.

The study, which was initiated in 2004 (Marketletter July 5, 2004), enrolled 424 chemo- and radiotherapy-naive patients who were randomized to receive either Erbitux and radiotherapy or radiotherapy alone.

Analysis of the results showed that, after the 54-month median follow-up assessment, the drug in combination with radiotherapy significantly prolonged overall survival, producing a 26% reduction in the risk of death when compared with radiotherapy alone. Additionally, the combined regimen produced a higher three-year survival rate than radiotherapy (55% versus 45%, p= 0.05 for all comparisons). Overall, the drug, given in combination, produced a 19.7 month improvement in median survival time and a 9.5 month increase in control of locoregional spread of the cancer beyond the head and neck.