Eli Lilly and Company announced results from a global Phase 3 study with Cyramza (ramucirumab) in combination with paclitaxel for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.
RAINBOW was a global, randomized, double-blinded, placebo-controlled study of ramucirumab and paclitaxel compared to placebo and paclitaxel in patients with advanced (locally advanced, unresectable, or metastatic) gastric cancer, including adenocarcinomas of the gastroesophageal junction refractory to or progressive after initial platinum- and fluoropyrimidine-containing chemotherapy.
The addition of ramucirumab to paclitaxel showed a statistically significant improvement in median overall survival, meeting its primary endpoint. 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 (stratified hazard ratio 0.807 [95% CI, 0.678–0.962; P=0.0169]). Treatment with ramucirumab plus paclitaxel significantly reduced the risk of disease progression or death by 37% with a 52% increase in median progression-free survival compared with placebo plus paclitaxel (4.4 months vs. 2.9 months; stratified hazard ratio 0.635 [95% CI, 0.536–0.752; P<0.0001]).
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