Data published in the New England Journal of Medicine show that Erbitux (cetuximab) significantly increases overall survival when added to standard chemotherapy in the 1st-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Results from the EXTREMEa trial also show that the addition of Erbitux to platinum-based chemotherapy significantly increases both median progression-free survival and tumour response rate, supporting the use of Erbitux in combination with chemotherapy as a new standard for 1st-line treatment of recurrent and/or metastatic SCCHN.

"These findings are very exciting as they represent the first breakthrough in the treatment of head and neck cancer in this disease setting in 30 years," commented Professor Jan B Vermorken, lead investigator of the EXTREME trial and head of the Department of Medical Oncology, Antwerp University Hospital, Belgium. "The inclusion of Erbitux as part of the standard 1st-line treatment regimen for SCCHN will give patients valuable time with prolonged symptomatic relief from the effects of this aggressive form of cancer that is so difficult to treat."

"The first data highlighting the potential of Erbitux as a treatment for head and neck cancer, from Bonner et al, were published in the New England Journal of Medicine in 2006," said Dr Anton Hoos, executive vice president, Global Development, Merck Serono. "The data resulting from the EXTREME study which have now been published in the NEJM are the next piece of the puzzle. They demonstrate the important role Erbitux can play in this treatment area - including 1st-line recurrent and/or metastatic disease which is an area of high unmet clinical need."

Erbitux is already approved for use in locally advanced SCCHN in combination with radiotherapy and the results of the EXTREME trial have been used to support an EMEA application to broaden the use of Erbitux to include 1st-line treatment of recurrent and/or metastatic SCCHN, submitted in June 2008.

Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR).