Erbitux (Cetuximab), a new drug which is used in combination with chemotherapy, increases overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck, according to ImClone, the company which introduced the drug together with Bristol-Myers Squibb.

A randomized, multi-center clinical trial (first Phase III Study), aimed at evaluating the impact of Erbitux treatment in combination with platinum-based chemotherapy on over survival in matastatic head an neck cancer, has produced “exciting results”.

The trial results have been submitted for presentation at the upcoming American Society of Clinical Oncology Meeting, June 2007, in Chicago, USA.

In the USA alone nearly 13,000 people die from head and neck cancer each year. Men have twice the risk of developing this cancer, compared to women – it most commonly strikes patients over 50 years of age. It is estimated that 81,550 Americans will be diagnosed with head and neck cancer in 2007.

The trial, known as EXTREME, treated over 400 patients. Half were given Erbitux in combination with cisplatin plus 5-fluorouracil (5-FU) or carboplatin plus 5-FU, while the other half were treated with cisplatin plus 5-FU or carboplatin plus 5-FU alone.

Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems, said “We are excited by the results of this study, as it is the first large, randomized clinical trial to examine the impact of Erbitux treatment in combination with platinum-based chemotherapy on overall survival in metastatic head and neck cancer. Erbitux has already demonstrated improved survival when combined with radiation in locoregionally advanced head and neck cancer.”

Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb, said “When ERBITUX was approved for head and neck cancer, it was not only hailed as the first new treatment for the disease in 45 years, but it was also the first drug approved to show a survival benefit in this population. Just one year later, this study adds to the growing body of clinical evidence with ERBITUX in these patients.”

— www.erbitux.com
— ImClone Systems
— Bristol-Myers Squibb

Written by: Christian Nordqvist
Editor: Medical News Today