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Mixed Phase III Results Reported for Cancer Drug Ramucirumab
Mixed results have been reported from two global phase III studies of ramucirumab (IMC-1121B, Eli Lilly) — one in advanced gastric cancer and the other in metastatic breast cancer.
The RAINBOW trial of ramucirumab in combination with paclitaxel in patients with advanced gastric cancer met its primary endpoint of improved overall survival (OS) and a secondary endpoint of improved progression-free survival (PFS).
The study compared ramucirumab and paclitaxel with placebo and paclitaxel in patients with locally advanced, unresectable, or metastatic gastric cancer that was refractory to or progressive after initial chemotherapy. No agents are currently approved in the U.S. for patients with advanced gastric cancer patients in this setting.
A separate phase III study of ramucirumab in women with locally recurrent or metastatic breast cancer (ROSE) did not meet its primary endpoint of PFS.
This randomized, double-blind trial compared ramucirumab and docetaxel with placebo and docetaxel as a first-line treatment in patients with unresectable, locally recurrent, or metastatic HER2-negative breast cancer. Effects on the primary endpoint of PFS in this study favored ramucirumab but were not statistically significant. The interim analysis for OS showed no benefit for ramucirumab.
Ramucirumab is designed to directly inhibit angiogenesis. The drug is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits the downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
Source: Eli Lilly; September 26, 2013.