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Title: Erbitux Proven Effective in Locoregional Squamous Cell Carcinoma of the Head and Neck: Presented at AACR-NCI-EORTC

"Erbitux Proven Effective in Locoregional Squamous Cell Carcinoma of the Head and Neck: Presented at AACR-NCI-EORTC"

By Maggie Schwarz PHILADELPHIA, PA -- November 17, 2005 -- Erbitux (cetuximab) has been proven to improve disease control and survival rates when used in conjunction with radiotherapy in locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). The benefits were achieved with minimal increases to the toxicity experienced with radiation, according to results presented here at the International Conference on Molecular Targets and Cancer: Discovery, Biology, and Clinical Applications. The conference is organized by the American Association for Cancer Research - National Cancer Institute - European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC). James Bonner, MD, Professor and Chairman, Department of Radiation Oncology, University of Alabama at Birmingham, Birmingham, AL, presented the results on November 16[^th.

Erbitux is a monoclonal antibody that binds specifically to epidermal growth factor receptors (EGFRs) on both normal and tumor cells, and completely inhibits the binding of epidermal growth factor and other ligands, such as transforming growth factor alpha. It is approved for EGFR-expressing, metastatic colorectal cancer that is refractory to irinotecan-based chemotherapy.

In the trial, median survival was 49 months with Erbitux plus radiation and 29 months with radiation alone, coupled with a 26% reduction in mortality risk. Three-year survival rates for Erbitux plus radiation were 56% and 45% for radiation alone.

Researchers enrolled 424 patients with locoregionally advanced SCCHN and randomized them to either radiation alone or radiation plus weekly Erbitux at an initial dose of 400 mg/m² and increased to 250 mg/m² for the remainder of radiation treatment.

Median patient age was 57 years, and 80% were male. Patients were stratified according to Karnofsky performance status, tumor stage, nodal involvement and radiotherapy treatment fractionation regimen.

"We believe the combination of Erbitux and radiotherapy represents a unique therapeutic option for treating patients with locoregional SCCHN," Dr. Bonner said. "These results will provide a much needed platform for additional efforts aimed at further improvements in outcomes."

Next steps for the investigators will be a randomized phase 3 study with 4 years of follow-up.

Dr. Bonner concluded that Erbitux is making radiotherapy more effective without exacerbating mucosal symptoms. There is a synergistic effect, resulting in greater cell death, he said. "We don't yet know the mechanism; multiple aspects of the cell cascade could be involved," he added.

[Presentation title: Cetuximab Improves Locoregional Control And Survival Of Locoregionally Advanced Head And Neck Cancer: Independent Review Of Mature Data With A Median Follow-up of 45 Months. Abstract B106]

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