ImClone Systems Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) have recently announced the results of two randomized Phase III trials of ERBITUX® (cetuximab) in metastatic colorectal cancer patients.
The said trials are the first large, randomized studies that examined the impact of ERBITUX® treatment on overall colon cancer survival.
A randomized, multicenter, Phase III trial (NCIC CTG CO.17) that compared ERBITUX® plus best supportive care to best supportive care alone in 572 patients with metastatic colorectal cancer whose disease was refractory to all available chemotherapy, including irinotecan, oxaliplatin, and fluoropyrimidines.
This study, conducted by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) in collaboration with the Australasian Gastro-Intestinal Trials Group (AGITG) met their primary efficacy endpoint which revealed a statistically significant improvement in overall survival.
The Erbitux Plus Irinotecan in Colorectal Cancer (EPIC), compared irinotecan to 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.
Though the primary endpoint of this study was not met, the secondary efficacy endpoints (progression free survival, response rate) strongly favored the combination of ERBITUX plus irinotecan over irinotecan alone. Results of the above study will be submitted for presentation at a major medical meeting in 2007.
Find more details from the press releases at ImClone and Bristol-Myers Squibb.
Comment Preview