IMCLONE, BMS REPORT MIXED RESULTS FROM ERBITUX STUDIES

ImClone Systems and Bristol-Myers Squibb (BMS) have announced results from two randomized Phase III trials of Erbitux (cetuximab) in patients with metastatic colorectal cancer. These are the first large, randomized studies to examine the impact of Erbitux treatment on overall survival in colon cancer.

One randomized, multicenter, Phase III trial compared Erbitux plus best supportive care with best supportive care alone in 572 patients with metastatic colorectal cancer whose disease was refractory to all available chemotherapy, including irinotecan, oxaliplatin and fluoropyrimidines. The study, conducted by the National Cancer Institute of Canada Clinical Trials Group in collaboration with the Australasian Gastro-Intestinal Trials Group, met its primary efficacy endpoint showing a statistically significant improvement in overall survival. These are the first data of an anticancer therapy to demonstrate overall survival in this refractory treatment setting.

A second Phase III, randomized study, known as the Erbitux Plus Irinotecan in Colorectal Cancer (EPIC) study, compared irinotecan with irinotecan plus Erbitux in approximately 1,300 patients whose disease was not responding to first-line oxaliplatin-based chemotherapy. After randomization, patients were treated until their disease progressed. Upon disease progression, study treatment was stopped and further treatment was at the discretion of the physician. Secondary efficacy endpoints (progression-free survival, response rate) strongly favored the combination of Erbitux plus irinotecan over irinotecan alone; however, the primary endpoint (overall survival) was not met.

Efforts to interpret these confounded results are ongoing. A preliminary review of the data reveal that a considerable number of patients randomized to the irinotecan arm went on to receive Erbitux with or without irinotecan after failing irinotecan alone.