Study of Cyramza in Gastric Cancer published in The Lancet Oncology-Eli Lilly

Eli Lilly has announced that results of the global Phase III trial of Cyramza (ramucirumab) in combination with paclitaxel in patients with advanced Gastric Cancer or gastroesophageal junction adenocarcinoma were published in the online version of The Lancet Oncology. In the trial, known as RAINBOW, the addition of ramucirumab to paclitaxel showed a statistically significant improvement in median overall survival, meeting its primary endpoint; it also met secondary endpoints of progression-free survival and objective response rate. Patients randomized to the ramucirumab-plus-paclitaxel arm had a median survival benefit of 9.6 months, compared to 7.4 months for patients on the placebo-plus-paclitaxel arm. Treatment with ramucirumab plus paclitaxel significantly reduced the risk of disease progression or death (by 37 percent), with a 52 percent increase in median progression-free survival compared with placebo plus paclitaxel (4.4 months vs. 2.9 months).

There was a statistically significant increase in objective response rate, from 16 to 28 percent, with the addition of ramucirumab. RAINBOW is the largest trial in second-line gastric cancer to date and the first Phase III study to demonstrate a survival benefit with a biologic used in combination with chemotherapy in this setting. See: "Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial." Hansjochen Wilke et al. The Lancet Oncology, Early Online Publication, 18 September 2014 doi:10.1016/S1470-2045(14)70420-6