Phase 3 trial results of Lilly’s ramucirumab

Eli Lilly & Company has announced top-line results from two of its global phase 3 clinical trials of ramucirumab – one in advanced gastric cancer and another in metastatic breast cancer.

While the RAINBOW clinical trial of ramucirumab, in combination with paclitaxel in patients with advanced gastric cancer, met its primary endpoint of improved overall survival, the separate ROSE study of the drug in women with metastatic breast cancer failed to meet its primary endpoint of progression-free survival.

"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."

Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology.

There are currently no agents specifically approved in the US or EU for advanced gastric patients who had had disease progression after initial chemotherapy. Lilly plans to submit an application for ramucirumab in combination with paclitaxel to regulatory authorities for this indication in due course.

On the other hand, Lilly will not be submitting an application to authorities about ramucirumab for the indication of breast cancer. The global pharma company will work together with the international cancer research group TRIO (Translational Research in Oncology) who helped conduct the trial to determine next steps for patients enrolled.

"Cancer is complex and patients with different tumor types may have varied responses due to distinct tumor biologies and individual patient characteristics. Unfortunately, anti-angiogenic agents have not yet been able to demonstrate an overall survival benefit for patients with metastatic breast cancer."

John Mackey, MD., principal investigator of the ROSE/TRIO-012 study and professor of oncology, University of Alberta.

"We are disappointed that this breast cancer trial did not meet its primary endpoint. However, now with two positive gastric cancer trials, Lilly remains confident in the overall ramucirumab development program. We are looking forward to additional Phase III results for ramucirumab in colorectal, hepatocellular and lung cancer, expected in 2014."

Dr. Gaynor, Lilly Oncology.