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Merck at ASCO 2007: Spectrum of Studies Reinforces Promise of,Erbitux for Colorectal and Head and Neck Cancer Patients

mber of complete resections in the overall population was three times higher in the Erbitux plus FOLFIRI arm.

“These encouraging results indicate that we have a new first-line treatment option for metastatic colorectal cancer,” said Eric Van Cutsem, MD, PhD, a professor at University Hospital Gasthuisberg in Leuven, Belgium, and lead author of the study. “These findings are remarkable because they point towards the potential for this combination to provide a cure for those patients who were able to undergo a complete resection.”

These results were supported by the findings of the OPUS(b) study. Erbitux plus FOLFOX (oxaliplatin-based therapy) was compared with FOLFOX alone to measure overall response rate (tumor shrinkage by 50% or more). Response rate was found to be 46% in the Erbitux arm compared with 36% in the oxaliplatin-only arm. The safety profile of Erbitux in combination with chemotherapy was manageable and consistent with the current safety information.

Overall, these first-line studies demonstrate that, when added to current standard chemotherapy, Erbitux significantly increases response and resection rates, which in turn, significantly increases the chance of cure for mCRC patients.

In recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) – which is notoriously difficult to treat – first-line Erbitux combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival. This phase III randomized controlled European trial, known as EXTREME(c), studied more than 400 patients treated with Erbitux in combination with either cisplatin- or carboplatin-based therapy compared with patients treated with platinum-based therapy alone. The trial represents a significant breakthrough and the first time in 35 years that a survival benefit has been demonstrated in this group of patients in a randomiz
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