Brivanib (BMS) fails in Phase III Colorectal Cancer Trial

According to a National Cancer Institute of Canada and Australasian Gastro-Intestinal Trials Group CO.20 Phase III study, overall survival was no better for advanced Colorectal Cancer patients with KRAS-normal tumors treated with brivanib alaninate, from BMS, plus cetuximab than for those treated with cetuximab alone. Although the combination appeared to improve response rates and progression-free survival, suggesting that brivanib may have activity for this disease, the unexpectedly large toxicity profile may have compromised efficacy. With a median follow-up of 19 months, the 376 patients in the combination arm had a median overall survival of 8.8 months, compared with 8.1 months for the 374 patients in the cetuximab-plus-placebo group. The difference was not statistically significant and did not meet the primary endpoint of an improvement of 3.2 months with the combination, noted Lillian Siu, Co-Director of the Robert and Maggie Bras and Family Drug Development Program at Princess Margaret Hospital and Professor of Medicine at the University of Toronto, who presented the results. Median progression-free survival for patients treated with brivanib-cetuximab was 5.0 months compared with 3.4 months for patients in the cetuximab-placebo arm, which was a statistically significant difference. The data was presented at the Gastrointestinal Cancers Symposium.