Data Available From Erbitux Phase III Study in First-Line Treatment,of Advanced Lung Cancer ( NEW YORK July 12 2007 /PRNewswire-Fi...)

Data Available From Erbitux Phase III Study in First-Line Treatment,of Advanced Lung Cancer

NEW YORK, July 12, 2007 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated and Bristol-Myers Squibb Company today announced results from an open-label Phase III study of ERBITUX(R) (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 favored 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, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.

"Lung cancer is a devastating disease with few effective treatment options," said Martin Birkhofer, M.D., 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."

About Lung Cancer

The American Cancer Society estimates that in the U.S., more than 213,000 people will be diagnosed with lung cancer in 2007. Lung cancer is the leading cause of cance
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