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news.Biopharmaceutical company ImClone Systems and Bristol-Myers Squibb have reported the results from a Phase III trial, published in the New England Journal of Medicine, in which Erbitux as a single agent demonstrated a significant improvement in overall survival in patients with metastatic colorectal cancer refractory to approved chemotherapy agents.
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The independent study (NCIC CTG CO.17) involved 572 patients and demonstrated that treating patients with Erbitux as a monotherapy plus best supportive care (BSC) significantly increased overall survival compared to BSC alone. BSC included palliative therapies designed to alleviate pain and treat other effects caused by metastatic colorectal cancer (mCRC).
Erbitux was administered at the recommended dose and schedule: 400mg/m2 initial dose, followed by 250mg/m2 weekly until disease progression or unacceptable toxicity.
In this study, the median survival was 6.1 months for patients treated with Erbitux plus BSC versus 4.6 months for patients on BSC alone. Treatment with Erbitux monotherapy resulted in a significant improvement in progression-free survival versus BSC alone. Twenty-three patients (8.0%) treated with Erbitux and no patients on BSC alone had partial responses.
Eric Rowinsky, chief medical officer and senior vice president of ImClone Systems, said: “This is the first time an antibody used as a single agent in colorectal cancer has demonstrated an overall survival benefit. These outcomes add to the growing body of evidence supporting the significant clinical benefits of Erbitux.”