CALGB Presents Results at ASCO from Randomized Study of Cetuximab and Chemotherapy in First-Line Metastatic Colorectal Cancer; Abstract #3509.

ATLANTA -- Enrollment Remains Ongoing in Follow-on Phase III CALGB Study of Cetuximab, Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer

The Cancer and Leukemia Group B today announced findings from a clinical trial of cetuximab and chemotherapy in previously untreated patients with metastatic colorectal cancer. This study was presented today in an oral session at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting by Alan Venook, M.D., Professor of Medicine, University of California, San Francisco on behalf of the CALGB.

A total of 238 patients with untreated metastatic adenocarcinoma of the colon or rectum were enrolled in the study and randomized to receive either chemotherapy (randomized between irinotecan/5FU/LV (FOLFIRI) or oxaliplatin/5FU/LV (FOLFOX)) or chemotherapy plus cetuximab. The study, CALGB 80203, was initiated in 2004 and was originally expected to recruit approximately 2,200 patients. Enrollment was closed after accrual of 238 patients due to an evolving standard of care in the first line treatment of metastatic colorectal cancer, including the emergence of bevacizumab as a component of therapy in this setting.

The primary endpoint of the study was overall survival and secondary endpoints included response rate, progression free survival and toxicity. Response rate among patients treated with the combination of cetuximab and chemotherapy was significantly higher than that for patients treated with chemotherapy alone (52% versus 38%, respectively, p=0.029). As the study was closed prematurely, it is not powered for statistical analysis of progression free- and overall survival.

"The early findings of CALGB 80203 have already demonstrated that the addition of cetuximab to chemotherapy significantly improves tumor response in the first line treatment of advanced colorectal cancer and it is important that we move rapidly to fully understand cetuximab's potential benefit in this disease setting," said Richard L. Schilsky, M.D., Group Chairman, CALGB.

"The ongoing NCI-sponsored trial, CALGB/SWOG 80405, is addressing this need," added Alan Venook, M.D., the principal investigator of both trials. "The 80405 trial brings to bear all the current advances in this disease setting, including chemotherapy and the targeted biologics cetuximab and bevacizumab, in the hope to further extend patient survival."

In September 2005, CALGB and the Southwest Oncology Group (SWOG) announced the initiation of a randomized, multicenter Phase III clinical trial designed to determine whether the addition of cetuximab to chemotherapy or to chemotherapy and bevacizumab prolongs survival compared to chemotherapy with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer. The enrollment of 2,289 patients in this study is ongoing in CALGB and SWOG and is open to all other cooperative group sites through the NCI Cancer Trials Support Unit (CTSU).

About CALGB

The Cancer and Leukemia Group B (CALGB) is a national clinical research group sponsored by the National Cancer Institute, with its Central Office headquartered at the University of Chicago and its Statistical Center located at Duke University. The CALGB was founded in 1956 with a goal of bringing together clinical oncologists and laboratory investigators to develop better treatments for cancer. Since 1956, CALGB has grown into a national network of 29 university medical centers, over 225 community hospitals and more than 3000 oncology specialists who collaborate in clinical research studies aimed at reducing the morbidity and mortality from cancer, relating the biological characteristics of cancer to clinical outcomes and developing new strategies for the early detection and prevention of cancer.