Eli Lilly says it will not seeking approval for its much-touted drug ramucirumab in breast cancer after it failed in a late-stage trial, but a Phase III study in gastric cancer proved more successful.

Most attention was on the breast cancer findings, which 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 favoured the Lilly drug but was not statistically significant, while an interim analysis for overall survival showed no benefit.

Lilly says it does not plan to submit an application to regulatory authorities for ramucirumab for the breast cancer indication. John Mackey, principal investigator of the study and professor of oncology at the University of Alberta, noted that "unfortunately, anti-angiogenic agents have not yet been able to demonstrate an overall survival benefit for patients with metastatic breast cancer".

On a brighter note, a Phase III study of ramucirumab in combination with paclitaxel in patients with advanced gastric cancer met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival. This is the second successful late-stage trial demonstrating an improvement in both overall and progression-free survival and filings will be submitted soon.

Richard Gaynor, head of product development and medical affairs at Lilly Oncology, acknowledged that "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 programme".

He added that the company is looking forward to additional Phase III results for ramucirumab in colorectal, hepatocellular and lung cancer, expected in 2014.