The study – known as CRYSTAL (1) Study – which recruited more than 1,000 patients worldwide, is the Phase III study of ImClone Systems Inc. (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)’s ERBITUX® (cetuximab) plus FOLFIRI (an irinotecan- based chemotherapy).
The said Phase III study met the primary endpoint of increasing median duration of progression-free survival over FOLFIRI alone in patients with previously untreated metastatic colorectal cancer (mCRC).
According to Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems:
"Despite advancements, metastatic disease remains difficult to treat. This study demonstrates the potential benefit of adding ERBITUX to first-line treatment of metastatic colorectal cancer.”
ERBITUX® is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1).
The abovementioned study was conducted by Merck KGaA (Darmstadt, Germany), ImClone Systems' ERBITUX partner outside of North America. Study results have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.
Find more details from the press release.
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