NEW YORKImClone Systems and Bristol-Myers Squibb have announced that a phase III study of cetuximab(Drug information on cetuximab) (Erbitux) plus FOLFIRI (an irinotecan(Drug information on irinotecan)-based chemotherapy regimen) met the primary endpoint of increasing median duration of progression-free survival (PFS) over FOLFIRI alone in patients with previously untreated metastatic colorectal cancer. More than 1,000 patients were recruited from around the world to participate in the study, known as the CRYSTAL study, the companies said. Results have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago in June.
"Despite advancements, metastatic disease remains difficult to treat. The study demonstrates the potential benefit of adding Erbitux to first-line treatment of metastatic colorectal cancer," said Eric Rowinksy, MD, CMO of ImClone.
Cetuximab is a monoclonal antibody designed to inhibit the function of EGFR. Erbitux in combination with radiotherapy is approved for locally or regionally advanced squamous cell carcinoma of the head and neck. As a single agent, it is indicated for patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.