Eli Lilly and Company announced top-line results from two global Phase 3 studies of ramucirumab (IMC-1121B), one in advanced gastric cancer and the other in metastatic breast cancer. 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.
RAINBOW is a global, randomized, double-blind, placebo-controlled trial of ramucirumab and paclitaxel compared to placebo and paclitaxel in 665 patients with 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. The primary endpoint of the RAINBOW trial is overall survival.
REGARD is a global, randomized, double-blind trial of ramucirumab and best supportive care compared to placebo and best supportive care as treatment in 355 patients with advanced gastric cancer, including adenocarcinomas of the gastro-esophageal junction following progression after initial chemotherapy.
ROSE is a Phase 3 randomized, double-blind trial, that compared ramucirumab and docetaxel to placebo and docetaxel as a first-line treatment in 1,144 patients with unresectable, locally recurrent or metastatic HER2-negative breast cancer. The primary endpoint of the study was progression-free survival.
The primary endpoint of improved overall survival was met in the RAINBOW trial. In the REGARD trial, single-agent ramucirumab improved overall survival and progression-free survival in patients with advanced gastric cancer who have had disease progression after initial chemotherapy. The primary endpoint in the ROSE trial was not met because progression-free survival with the use of ramucirumab in women with locally recurrent or metastatic breast cancer was not statistically significant. The interim analysis for overall survival in this trial showed no benefit for ramucirumab.