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Eli Lilly And Co Announces Single-Agent Ramucirumab Improves Overall Survival In Advanced Gastric Cancer Patients

Thursday, 3 Oct 2013 08:00am EDT 

Eli Lilly And Co announced that results from the Phase III REGARD trial of ramucirumab (IMC-1121B) as a single agent in patients with advanced gastric cancer who have had disease progression after initial chemotherapy were published on October 03, 2013 in The Lancet. REGARD is the first Phase III study with either a single-agent biologic or an anti-angiogenic therapy to show improved overall survival and progression-free survival in advanced gastric cancer patients. Patients treated with single-agent ramucirumab (n=238) achieved a median overall survival of 5.2 months compared to 3.8 months for patients on the placebo arm (n=117), representing a 37% increase. The overall survival hazard ratio was 0.776 (95% CI, 0.603-0.998; p=0.0473), which corresponds to a 22% reduction in risk of death. Patients on the ramucirumab arm achieved a median progression-free survival of 2.1 months compared to 1.3 months for those on the placebo arm. The progression-free survival hazard ratio was 0.483 (95% CI, 0.376-0.620; p <0.0001). In the REGARD analysis reported in The Lancet, the following adverse events occurred at a higher rate (for Grade 3 or higher) on the ramucirumab arm: hypertension (8% on ramucirumab vs 3% on placebo) and abdominal pain (6% vs 3%). No Grade 4 hypertension was observed on the ramucirumab arm. 

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