Mixed Results for Lilly’s Ramucirumab

Eli Lilly and Co. has posted top-line results from RAINBOW and ROSE, two global Phase III studies of ramucirumab (IMC-1121B) in advanced gastric cancer and another in metastatic breast cancer. The drug, in combination with paclitaxel, met its primary endpoint in gastric cancer, improving overall survival, and also met its secondary endpoint of improved progression-free survival. However, a separate trial of ramucirumab in women with locally recurrent or metastatic breast cancer did not meet its primary endpoint of progression-free survival.

The global, randomized, double-blind RAINBOW trial compared ramucirumab and paclitaxel to placebo and paclitaxel in patients with advanced (locally advanced, unresectable or metastatic) gastric cancer that was refractory to or progressive after initial chemotherapy.

“We are excited to see a second positive Phase III trial of ramucirumab in gastric cancer demonstrating an improvement in both overall survival and progression-free survival, as stomach cancer is a difficult-to-treat disease that remains a major health problem worldwide and the prognosis for patients diagnosed with advanced gastric cancer is poor,” said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology.

This breast cancer trial, ROSE, is being conducted with the international cancer research group TRIO (Translational Research in Oncology). The randomized, double-blind ROSE trial, also known as TRIO-012, compared ramucirumab and docetaxel to placebo and docetaxel as a first-line treatment in patients with unresectable, locally recurrent or metastatic HER2-negative breast cancer. The primary endpoint of progression-free survival in this study favored ramucirumab but was not statistically significant. The interim analysis for overall survival showed no benefit for ramucirumab.

Lilly and TRIO will work together to determine next steps for patients enrolled in the  ramucirumab breast cancer study, and plan to present data from this trial at an upcoming scientific meeting. Lilly does not plan to submit an application to regulatory authorities for ramucirumab in the first-line treatment of locally recurrent or metastatic HER2-negative breast cancer based on the results from this study.

The company is expecting additional Phase III results for ramucirumab in colorectal, hepatocellular and lung cancer in 2014.