Erbitux Phase III head and neck data

ImClone (IMCL), Merck KGaA (FSE:MRK) and Bristol-Myers (BMY) said their Erbitux cetuximab met the primary endpoint in a Phase III trial in advanced squamous cell carcinoma of the head and neck. In the international study in 424 patients, 69% and 56% of patients receiving Erbitux plus high-dose radiation met the primary endpoint of locoregional control at one and two years, respectively, compared with 59% and 48% of patients treated with high-dose radiation alone (p=0.02). The percentage of patients alive at two and three years post-treatment was 62% and 57% for the Erbitux group versus 55% and 44% for those treated with radiation alone (p=0.02). Median overall survival for Erbitux-treated patients was 54 months compared to 28 months for patients treated with radiation alone. The monoclonal antibody against epidermal growth factor is marketed to treat metastatic colorectal cancer in patients refractory to or intolerant of irinotecan-based chemotherapy.

In 2002, Erbitux plus cisplatin failed to show a significant improvement in progression-free survival compared to cisplatin alone in a U.S. Phase III trial of 123 head and neck cancer patients. ...