Merck KGaA and its Merck Serono division announced that it has received approval from the European Commission to extend the use of its targeted therapy Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Erbitux was previously approved for use in combination with radiotherapy for locally advanced disease.
The approval is 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.
Patients treated with Erbitux plus chemotherapy experienced - median overall survival increase of nearly three months (10.1 vs. 7.4 months, p=0.04), equating to a 20 per cent reduction in the risk of death (HR: 0.80) during the study period; 70 per cent increase in median progression-free survival (5.6 vs. 3.3 months; p<0.001); 80 per cent relative increase in response rate (36 per cent vs 20 per cent; p<0.001).
"To receive approval for Erbitux in the first-line treatment of recurrent and/or metastatic SCCHN is fantastic news. We hope that patients and specialists are equally encouraged by this first significant advance in this treatment setting in 30 years," said Dr Wolfgang Wein, executive vice president, Oncology, Merck Serono. "This latest approval recognizes the impressive potential of Erbitux to extend patients' lives and further confirms the high activity of Erbitux against difficult to treat cancers."
In Europe alone, it is estimated that there are around 143,000 cases of head and neck cancer, and more than 68,000 deaths due to the disease, each year. About 40 per cent of patients with head and neck cancer have recurrent and/or metastatic SCCHN. Head and neck cancer is the sixth-most common cancer worldwide and includes cancers of the tongue, mouth, salivary glands, pharynx, arynx, sinuses, and other sites located in the head and neck area. Erbitux targets the epidermal growth factor receptor (EGFR). About 90 per cent of head and neck cancers are of the squamous cell variety and nearly all express the EGFR, which is critical for tumour growth.
Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR).