ImClone Systems Incorporated and Bristol-Myers Squibb Company has announced results from an open-label phase III study of Erbitux (Cetuximab) plus a taxane and carboplatin in the first-line treatment for metastatic non-small cell lung cancer (NSCLC).

The study did not meet its primary endpoint of progression-free survival (PFS) as assessed by an independent radiology review committee (IRRC). However, key secondary endpoints of the study, including response rate as assessed by the IRRC and PFS as assessed by clinical investigators, were statistically significant and favoured the Erbitux- containing arm.

Known as BMS CA225-099, this study included more than 600 patients from the United States and Canada and was one of several clinical trials intended to establish the role of Erbitux in the treatment of advanced NSCLC. Data from the largest of these trials, an ongoing multinational phase III study of Erbitux plus cisplatin and vinorelbine intended to be the pivotal study for the Erbitux NSCLC regulatory strategy, are not yet available.

"We consider lung cancer to be a high priority and await the results of other phase II and phase III evaluations of Erbitux in the first- and second- line setting with chemotherapy regimens," stated Eric K Rowinsky, MD, chief medical officer and senior vice president of ImClone Systems.

"Lung cancer is a devastating disease with few effective treatment options," said Martin Birkhofer, MD, vice president, oncology global medical affairs, Bristol-Myers Squibb. "Efforts to fully interpret these results are ongoing, and the companies plan to submit the data from this study to an upcoming medical meeting in 2007."

The American Cancer Society estimates that in the US, more than 213,000 people will be diagnosed with lung cancer in 2007. Lung cancer is the leading cause of cancer-related death in men and women in the US, with 160,000 deaths estimated in 2007. Approximately 80 to 85 per cent of these patients will be diagnosed with NSCLC, with the majority being diagnosed with locally advanced or metastatic disease.