LY 3009806 fails to meet endpoint in Breast Cancer study

A global Phase III study of LY 3009806 (ramucirumab), from Eli Lilly, in women with locally recurrent or metastatic Breast Cancer did not meet its primary endpoint of progression-free survival (PFS). The randomized, double-blind trial (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 PFS in this study favored ramucirumab but was not statistically significant. The interim analysis for overall survival showed no benefit for ramucirumab.

The most common adverse events on the ramucirumab-plus-docetaxel arm included fatigue/asthenia, neutropenia, febrile neutropenia, hypertension and stomatitis. 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.