Lilly Announces Second Positive Phase III Gastric Cancer Study

INDIANAPOLIS, Sept. 26, 2013 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced top-line results from two global Phase III studies of ramucirumab (IMC-1121B), one in advanced gastric cancer and another in metastatic breast cancer.

The RAINBOW trial, a global 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.

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. The most common ( > 5% incidence) Grade > 3 adverse events occurring at a higher rate on the ramucirumab-plus-paclitaxel arm compared to the control arm included neutropenia, leukopenia, hypertension, fatigue/asthenia and abdominal pain.