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Phase III Study Evaluates Ramucirumab as Single Agent in Gastric Cancer
The phase III REGARD trial — a study of ramucirumab (IMC-1121B; Eli Lilly) in patients with metastatic gastric cancer — has met its primary endpoint of improved overall survival and also showed prolonged progression-free survival, according to a recent report.
The REGARD trial compared ramucirumab and best supportive care (BSC) with placebo and BSC as second-line treatment of metastatic gastric or gastroesophageal-junction adenocarcinoma following disease progression during first-line platinum- or fluoropyrimidine-containing combination therapy.
The primary endpoint of the study was overall survival. Secondary endpoints included progression-free survival; the proportion of participants who were progression-free at week 12; the proportion of participants with an objective response; the duration of response; and safety.
The most frequent adverse reaction occurring at a higher rate in the ramucirumab arm than in the placebo arm was hypertension (12%). Other adverse reactions occurring at a higher rate in the ramucirumab arm were diarrhea and headache.
Ramucirumab is a fully human IgG1 monoclonal antibody receptor antagonist designed to bind the extracellular domain of vascular endothelial growth factor (VEGF) receptor-2, thereby blocking the interaction of VEGF ligands (VEGF-A, VEGF-C, and VEGF-D) and inhibiting receptor activation. VEGF receptor-2 is considered a primary mediator of angiogenesis. When activated by VEGF ligands, VEGF receptor-2 promotes endothelial cell proliferation and survival, migration, and vascular permeability.
Source: Eli Lilly, October 15, 2012.