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Lilly Announces Second Positive Ramucirumab Phase III Gastric Cancer Study Meets Primary Endpoint; Phase III Lilly/TRIO Breast Cancer Study Misses Primary Endpoint
Date:9/26/2013

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.

"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. 

The first positive study, REGARD, showed single-agent ramucirumab improved overall survival and progression-free survival in patients with advanced gastric cancer who have had disease progression after initial chemotherapy.  There are no agents specifically approved in the U.S. or EU for advanced gastric cancer patients in this setting.

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SOURCE Eli Lilly and Company
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