Source: www.vwd.de
Author: press release

The American Society of Clinical Oncology (ASCO) has once again recognized Erbitux® (cetuximab) as one of the major clinical cancer advances of 2009. This year Erbitux was selected by ASCO for providing the first significant increase in survival for 30 years in the treatment of patients with first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck(SCCHN).1

ASCO Clinical Advances Report1
The ASCO report, ‘Clinical Cancer Advances 2009: Major Research Advances in Cancer Treatment, Prevention and Screening’, published this week in the Journal of Clinical Oncology, is an independent assessment of the most significant clinical cancer research studies of the past year.

Erbitux was singled out for the pivotal first-line SCCHN study, the first randomized trial in 30 years to identify a regimen that increases survival for patients with recurrent and/or metastatic SCCHN. The report commented that, “The ability to improve overall survival with chemotherapy has proven elusive over the last 30 years in several randomized trials comparing different chemotherapy regimens in this setting. Thus, the results of this trial are particularly noteworthy and are changing clinical practice.”

This is the second consecutive year that Erbitux has featured in the ASCO ‘Advances’ list.3 In 2008 it was recognized for extending survival in the first-line treatment of NSCLC and for the role of KRAS tumor status in predicting whether patients with newly diagnosed metastatic colorectal cancer will respond to Erbitux.2

“Merck Serono is honored that Erbitux is recognized by ASCO two years in a row, and across three different disease areas – colorectal cancer, lung cancer and now head and neck cancer, as a major clinical advance,” commented Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “This latest acknowledgement from ASCO is a tribute to the role Erbitux now plays as a gold standard therapy in first-line recurrent and/or metastatic SCCHN”.

The study demonstrated that SCCHN patients treated with Erbitux plus chemotherapy experienced the following improvements, compared to chemotherapy alone:3
– Median overall survival (OS) increased by nearly 3 months (10.1 vs. 7.4 months; p=0.04), equating to a 20% reduction in the risk of death (Hazard Ratio [HR] 0.80) during the study period
– 46% 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)
– Based on the EXTREME study, the ESMO Guidelines Working Group earlier this year recommended Erbitux as the only treatment with a grade of recommendation ‘A’ and level of evidence ’I’^4

Long-Term Survival Results in Locally Advanced SCCHN
Also this week, the 5-year survival data from the Bonner trial for Erbitux in locally advanced (LA) SCCHN were published in the Lancet Oncology. The Phase III Bonner trial formed the basis for the initial Erbitux LA SCCHN license, granted in Europe in 2006. This new long-term analysis provides further support for the combination of Erbitux and radiotherapy in the treatment of LA SCCHN, demonstrating:^5
– Almost half of patients receiving Erbitux plus radiotherapy are still alive at 5 years – in contrast to only one third of patients receiving  radiotherapy alone (45.6% vs. 36.4%; p=0.018)
– Adding Erbitux to radiotherapy leads to a sustained survival benefit (OS
49.0 vs. 29.3 months; HR 0.725; p=0.018)
– The development of prominent skin rash is associated with an additional survival benefit leading to a reduction in the risk of death of 51%

Head and Neck Cancer
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. 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 in Europe each year.^6 About 90% of head and neck cancers are of the squamous cell variety^7 and nearly all express the epidermal growth factor receptor which is critical for tumor growth.8 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN.9 At least 75% of all head and neck cancers are attributed to two major risk factors, smoking and alcohol consumption.10

References
1 . Petrelli NJ, et al. J Clin Oncol 2009;ePub ahead of print November 6, 2009.
2 . Winer E, et al. J Clin Oncol 2009;27(5):812-26.
3 . Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
4 . Licitra L, & Felip E. Ann Oncol 2009;20(Suppl 4):iv121–iv122.
5 . Bonner J, et al. Lancet Oncol 2009;ePub ahead of print November 7, 2009.
6 . GLOBOCAN 2002 (www-dep.iarc.fr), accessed November 2009.
7 . Vermorken J. Ann Oncol 2005;16(Suppl 2):ii258-ii264.
8 . Grandis JR & Tweardy DJ. Cancer Res 1993;53(15):3579-84.
9 . Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
10 . Hashibe M, et al. J Natl Inst 2007;99:777-89