ImClone Systems Incorporated and Bristol-Myers Squibb Company announced that a first-line phase III study of cetuximab(Drug information on cetuximab) (Erbitux) 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 randomized, multicenter study, known as EXTREME, enrolled more than 400 patients treated with cetuximab in combination with either cisplatin plus fluorouracil(Drug information on fluorouracil) (5-FU) or carboplatin(Drug information on carboplatin) plus 5-FU, compared to patients treated with cisplatin(Drug information on cisplatin) plus 5-FU or carboplatin plus 5-FU alone.
"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," said Eric Rowinsky, MD, chief medical officer and senior vice president of ImClone Systems. "Erbitux has already demonstrated improved survival when combined with radiation in locoregionally advanced head and neck cancer."
"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 1 year later, this study adds to the growing body of clinical evidence with Erbitux in these patients," said Martin Birkhofer, MD, vice president, oncology global medical affairs, Bristol-Myers Squibb.
Results from this study have been submitted for presentation at the June 2007 American Society of Clinical Oncology annual meeting in Chicago.