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

ed Phase III trial.

As well as first-line use, new findings were also presented at ASCO on the use of Erbitux in previously treated patients. New data from the phase III EPIC(d) study, which compared Erbitux plus irinotecan-based therapy with irinotecan-based therapy alone in mCRC patients who had failed first-line treatment with oxaliplatin-based chemotherapy, showed that health-related quality of life was significantly improved in the Erbitux arm, along with progression-free survival and response rate. Using a validated Quality of Life assessment tool, a statistically significant difference in favor of the Erbitux arm was seen in 10 of the 15 symptom scales, including pain (p<0.0001), nausea (p<0.0001) and global health status (p=0.047).

“The first set of data from the EPIC trial demonstrated that progression-free survival and tumor shrinkage increased significantly when Erbitux was administered to this patient population. It is therefore very encouraging to see from this new data, a significant clinical advantage with Erbitux according to subjective as well as objective parameters,” said lead investigator Professor Alberto Sobrero, Hospedale San Martino, Genova, Italy. “For mCRC patients, feeling better while reaping the benefits of targeted therapy is clearly of great importance.”

The Latin American LABEL(e) study demonstrates the therapeutic potential of Erbitux in a heavily pre-treated patient population, 24% of which had received three or more prior therapies for mCRC. In this single arm study, Erbitux plus irinotecan achieved an overall response rate of 27%, a median progression-free survival duration of more than 4 months, and an overall median survival of 9.7 months, confirming the consistent activity of Erbitux seen in previous studies.

“We are delighted with the results of these trials presented at ASCO,” said Dr Wolfgang Wein, Senior Executive Vice President, Oncology, Merck Serono –
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