There are no agents specifically approved in the United States or European Union for advanced gastric cancer patients. Gastric cancer is the fourth most common cancer in the world and the second-leading cause of cancer-related death.
The REGARD trial found that the patients who received Ramucirumab had a significant improvement in their survival as well as reducing the rate of cancer progression.
The side effects associated with Ramucirumab, except for hypertension, were mostly similar to what patients receiving placebo experienced.
Ramucirumab is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor ( VEGF ) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
REGARD is a global, randomized, double-blind, placebo-controlled phase III study of Ramucirumab and best supportive care compared to placebo and best supportive care as treatment in patients with advanced gastric cancer ( including adenocarcinomas of the gastro-esophageal junction ) following progression after initial chemotherapy.
In total, 355 patients were randomized in 29 countries. Patients enrolled in this study in general had poor prognostic factors; 36% were age 65 or older, 31% had peritoneal metastases, and 67% had disease progression within six months after initiation of their previous therapy.
The adverse events in The Lancet reported selected events that occurred at a rate of 10% or higher ( any grade ) and 2% or higher ( grade 3 or higher ), as well as adverse events of special interest that were evaluated due to the mechanism of action of drug.
RAINBOW is a global, randomized, double-blind, placebo-controlled phase III study of Ramucirumab and Paclitaxel compared to placebo and Paclitaxel in patients with advanced ( locally advanced, unresectable or metastatic ) gastric cancer ( including adenocarcinomas of the gastro-esophageal junction ) refractory to or progressive after initial chemotherapy containing Platinum and fluoropyrimidine. Initiated in 2010, the global study randomized a total of 665 patients across 27 countries in North America, South America, Europe, Australia and Asia. ( Xagena )
Source: Lilly, 2013