Source: www.medadnews.com
Author: press release

Today leading oncology specialists and media gathered at the Antwerp University Hospital to mark the European launch of Erbitux® (cetuximab) for the 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), following European Commission approval to extend the use of the targeted therapy. Erbitux was previously approved for use in combination with radiotherapy for locally advanced SCCHN.

The approval of Erbitux in this new indication was granted in November 2008 and based primarily upon the results of the EXTREMEa study, published in the New England Journal of Medicine in September 2008. The EXTREME study established that adding Erbitux to platinum-based chemotherapy significantly prolonged median overall and progression-free survival, and also significantly increased response rate.1

The principal investigator of the EXTREME trial, Professor Jan Vermorken from the Antwerp University Hospital, a world renowned center of excellence in oncology research and treatment said: “We are pleased to be hosting the international launch of Erbitux in this notoriously difficult to treat cancer type. This is the first treatment regimen in 30 years to show a survival benefit and denotes a significant milestone in the advancement of treatment for head and neck cancer.”

The EXTREME study demonstrated that patients treated with Erbitux plus chemotherapy experienced the following improvements, compared to chemotherapy alone:1
• Median overall survival increase of nearly 3 months (10.1 vs. 7.4 months; p=0.04), equating to a 20% reduction in the risk of death (HR: 0.80) during the study period
• 70% relative increase in median progression-free survival (5.6 vs. 3.3 months; p<0.001)
• Almost doubling of response rate (36% vs. 20%; p<0.001)

Concurrent with the launch of Erbitux, preliminary results were released from a new European survey “About Face”, which was conducted by the European Head and Neck Society (EHNS) to investigate the awareness of head and neck cancer among the general public. The results showed alarmingly low levels of knowledge about the symptoms, risk factors and body parts affected by the disease2 despite it being the sixth-most common cancer worldwide .3

In Europe alone, it is estimated that there are around 143,000 new cases of head and neck cancer and more than 68,000 deaths due to the disease each year.4 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN.5 Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinuses and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety6 and nearly all express the epidermal growth factor receptor (EGFR) which is critical for tumor growth.7 Erbitux targets the EGFR. Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have second primary tumors in addition to suffering from other co-morbidities.8 At least 75% of all head and neck cancers are attributed to two major risk factors, smoking and alcohol consumption.9

“We are honored to launch Erbitux in the 1st-line treatment for recurrent and/or metastatic SCCHN at a facility renowned for its pioneering work into head and neck cancer,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. “We hope that patients and specialists alike are encouraged by this first significant advance in this treatment setting in 30 years. Today’s launch reinforces the impressive potential of Erbitux to extend patients’ lives and further confirms the high activity of Erbitux against difficult to treat cancers.”

a EXTREME: ErbituX in 1st-line Treatment of REcurrent or MEtastatic head and neck cancer

References:
1. Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
2. About Face survey [TNS Healthcare 2008. ‘About Face’ Head and Neck Cancer Awareness – EU Omnibus Survey
3. Hunter KD, et al. Nat Rev Cancer 2005;Feb;5(2):127-35
4. GLOBOCAN 2002 (www-dep.iarc.fr), accessed November 2008.
5. Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
6. Vermorken J. Ann Oncol 2005;16(Suppl 2):ii258-ii264.
7. Grandis JR & Tweardy DJ. Cancer Res 1993;53(15):3579-84.
8. Forastiere A, et al. N Engl J Med 2001;345(26):1890-1900.
9. Hashibe M, et al. J Natl Inst 2007;99:777-89.