The results of an international phase III study evaluating 1,072 patients with advanced colorectal cancer whose disease progressed on or after initial therapy will be presented at the upcoming Gastrointestinal Symposium in San Francisco. The trial results suggest that a combination of the targeted drug Cyramza™ (ramucirumab) and FOLFIRI chemotherapy provides a survival advantage over standard treatment with FOLFIRI alone.
According to estimates from the American Cancer Society, more than 102,000 new cases of colon cancer and about 40,000 new cases of rectal cancer were diagnosed in the United States in 2013. Together, the diseases were responsible for over 50,000 deaths. There is, however, good news about colorectal cancer in the United States: death rates associated with the disease have dropped during the past 15 years, and advances continue to be made in screening, prevention, and treatment. Unfortunately many individuals will fail initial therapy and develop metastatic disease. Continued development of drugs to treat metastatic colon cancer is necessary to further improve outcomes.
Cyramza™ is a type of targeted agent known as a monoclonal antibody. It belongs to a class of drugs known as angiogenesis inhibitors. It works by blocking the growth of new blood vessels to the cancer, essentially starving it of nutrients. The agent is currently FDA approved for the treatment of gastric cancer and it is being studied in colon and other cancers.
In this clinical study, 1,072 patients with advanced colorectal cancer whose disease progressed on or after initial therapy were treated with FOLFIRI (leucovorin/5-fluorouracil/irinotecan) with our without Cyramza™ and directly compared.
The study found that although shrinkage rates were similar in the two treatment groups, the addition of Cyramza™ to FOLFIRI led to a moderate improvement in time to disease progression and overall survival when compared to treatment with FOLFIRI alone. On average Cyramza™ treated patients survived 13.3 months compared with 11.7 months for treatment with FOLFIRI alone.
Reference: Tabernero J, Cohn AL, Obermannova R, et al. RAISE: A randomized, double-blind, multicenter phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab (RAM) or placebo (PBO) in patients (pts) with metastatic colorectal carcinoma (CRC) progressive during or following first-line combination therapy with bevacizumab (bev), oxaliplatin (ox), and a fluoropyrimidine (fp). 2015 Gastrointestinal Cancers Symposium; January 15-17, 2015; San Francisco, CA. Abstract 512.