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news.Data from a Phase III study has shown that Erbitux, a cancer drug developed by ImClone Systems and Bristol-Myers Squibb, failed to stop lung cancer from progressing in patients with advanced stages of the disease
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The trial, an open-label Phase III study of Erbitux plus a taxane and carboplatin in the first-line treatment for metastatic non-small cell lung cancer (NSCLC), did not meet its primary endpoint of progression-free survival (PFS) as assessed by an independent radiology review committee (IRRC).
However, the companies say 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, the study included more than 600 patients from the US and Canada and was one of several clinical trials intended to establish the role of Erbitux in the treatment of advanced NSCLC.
“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, chief medical officer and senior vice president of ImClone Systems.
The companies plan to submit the data from this study to an upcoming medical meeting in 2007.