ImClone Systems and its partners Bristol-Myers Squibb and Merck KGaA are celebrating after the latter presented promising data suggesting that Erbitux can be a first-line treatment for head and neck cancer.

Merck said that a first-line Phase III study of Erbitux (cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The randomised, multi-centre study, called Extreme, analysed more than 400 patients treated in Europe with Erbitux in combination either with cisplatin plus 5-fluorouracil (5-FU) or carboplatin plus 5-FU, compared with patients treated with cisplatin plus 5-FU or carboplatin plus 5-FU alone.

At present, Erbitux is approved for head and neck cancer as a second-line therapy, as well as for the treatment of colorectal cancer, and this first-line data, if it results in an extended label, will provide a substantial boost to sales. Merck licensed marketing rights to Erbitux outside North America from ImClone in 1998, and gaining another approval could push the German company’s sales of the drug to around 800 million euros, analysts have estimated.

The estimated incidence of head and neck cancers in Europe is around 140,000 annually, with over 65,000 deaths per year, Merck noted. Currently, median survival for patients with recurrent or metastatic disease is only about six months.