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news.ImClone Systems and Bristol-Myers Squibb have reported mixed results of two phase III trials of Erbitux, where one study failed but the other met its primary goal.
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The trials were designed to evaluate Erbitux in patients with metastatic colorectal cancer.
The first phase III trial compared Erbitux plus best supportive care to best supportive care alone in patients with colorectal cancer whose disease was refractory to all available chemotherapy. The data achieved its goal and demonstrated overall survival in this refractory treatment setting.
“This is the second tumor type where Erbitux has shown survival benefit,” said Eric Rowinsky, chief medical officer of ImClone Systems. “Additionally, no other EGFR-targeted therapy has demonstrated an improvement in overall survival in a phase III colorectal cancer clinical study.”
A second phase III study compared irinotecan to irinotecan plus Erbitux in patients whose disease was not responding to first-line oxaliplatin-based chemotherapy. Secondary efficacy endpoints such as progression free survival and response rate strongly favored the combination of Erbitux plus irinotecan. However, the primary endpoint of overall survival was not met.
ImClone Systems said it planned to discuss registration submission with the FDA despite the mixed results.