Erbitux recognized as one of the major clinical cancer advances of 2009

MerckNov 16 2009

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 1^st-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

ASCO Clinical Advances Report

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 1^st-line SCCHN study, EXTREME^a, 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 [EXTREME] trial are particularly noteworthy and are changing clinical practice.”

This is the second consecutive year that Erbitux has featured in the ASCO ‘Advances’ list. In 2008 it was recognized for extending survival in the 1^st-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.

“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 1^st-line recurrent and/or metastatic SCCHN”.

The EXTREME study demonstrated that SCCHN patients treated with Erbitux plus chemotherapy experienced the following improvements, compared to chemotherapy alone:

• Median overall survival (OS) increased by nearly 3 months (10.1 vs. 7.4 months;>
• 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’