ImClone Systems (IMCL) Reports Positive Data From Phase II OPUS Study with Additional of ERBITUX
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ImClone Systems Incorporated (NASDAQ: IMCL) announced data from the Phase II OPUS study that show that the addition of ERBITUX to FOLFOX chemotherapy significantly improves both response rate and progression-free survival over FOLFOX alone in the first-line treatment of metastatic colorectal cancer (mCRC) patients whose tumors do not have mutations of the K-Ras oncogene (K-Ras wild-type). The study results have been published on the American Society of Clinical Oncology (ASCO) web site, www.asco.org.
The OPUS study is a randomized first-line Phase II study of 337 patients comparing ERBITUX plus FOLFOX to FOLFOX alone in epidermal growth factor receptor (EGFR)-expressing mCRC patients who have not previously been treated. Oxaliplatin-based chemotherapy regimens, including FOLFOX, are used in the majority of first-line colorectal cancer patients in the U.S. Response rate, the OPUS study's primary endpoint, was found to be 46% in the ERBITUX-plus-FOLFOX arm compared with 36% in the FOLFOX-only arm (P = .064). [SM]
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