Ramucirumab Improves Survival in Gastric Cancer Patients
Phase III trial supports single-agent therapy (October 3)
The Lancet has published positive results from a phase III study of ramucirumab (IMC-1121B, Eli Lilly) as a single agent in patients with advanced gastric cancer who have had disease progression after initial chemotherapy.
The global, randomized, double-blind REGARD trial 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.
The study evaluated ramucirumab plus best supportive care versus placebo and best supportive care as treatment in patients with advanced gastric cancer following progression after initial chemotherapy. A total of 355 patients were randomly assigned to receive best supportive care plus either ramucirumab 8 mg/kg or placebo intravenously once every 2 weeks. The median duration of treatment was 8 weeks in the ramucirumab group and 6 weeks in the placebo group.
Patients treated with single-agent ramucirumab (n = 238) achieved median overall survival of 5.2 months compared with 3.8 months for patients in the placebo arm (n = 117), representing a 37% increase. The overall survival hazard ratio (HR) was 0.776 (P = 0.0473), which corresponds to a 22% reduction in the risk of death.
In addition, patients in the ramucirumab arm achieved median progression-free survival of 2.1 months compared with 1.3 months for those in the placebo arm. The progression-free survival HR was 0.483 (P < 0.0001).
Ramucirumab is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2, thereby inhibiting downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
Source: Eli Lilly; October 3, 2013.