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Ref Type Journal Article
PMID (24094768)
Authors Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J, null null
Title Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial.
Journal Lancet (London, England)
Vol 383
Issue 9911
Date 2014 Jan 04
URL
Abstract Text Vascular endothelial growth factor (VEGF) and VEGF receptor-2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer. We aimed to assess whether ramucirumab, a monoclonal antibody VEGFR-2 antagonist, prolonged survival in patients with advanced gastric cancer.We did an international, randomised, double-blind, placebo-controlled, phase 3 trial between Oct 6, 2009, and Jan 26, 2012, at 119 centres in 29 countries in North America, Central and South America, Europe, Asia, Australia, and Africa. Patients aged 24-87 years with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression after first-line platinum-containing or fluoropyrimidine-containing chemotherapy were randomly assigned (2:1), via a central interactive voice-response system, to receive best supportive care plus either ramucirumab 8 mg/kg or placebo, intravenously once every 2 weeks. The study sponsor, participants, and investigators were masked to treatment assignment. The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00917384.355 patients were assigned to receive ramucirumab (n=238) or placebo (n=117). Median overall survival was 5·2 months (IQR 2·3-9·9) in patients in the ramucirumab group and 3·8 months (1·7-7·1) in those in the placebo group (hazard ratio [HR] 0·776, 95% CI 0·603-0·998; p=0·047). The survival benefit with ramucirumab remained unchanged after multivariable adjustment for other prognostic factors (multivariable HR 0·774, 0·605-0·991; p=0·042). Rates of hypertension were higher in the ramucirumab group than in the placebo group (38 [16%] vs nine [8%]), whereas rates of other adverse events were mostly similar between groups (223 [94%] vs 101 [88%]). Five (2%) deaths in the ramucirumab group and two (2%) in the placebo group were considered to be related to study drug.Ramucirumab is the first biological treatment given as a single drug that has survival benefits in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma progressing after first-line chemotherapy. Our findings validate VEGFR-2 signalling as an important therapeutic target in advanced gastric cancer.ImClone Systems.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Ramucirumab Ramucirumab 10 13
Drug Name Trade Name Synonyms Drug Classes Drug Description
Ramucirumab Cyramza LY3009806 VEGFR2 Antibody 4 Cyramza (ramucirumab) is a monoclonal antibody, which binds and inhibits VEGFR2 (KDR) resulting in decreased angiogenesis (PMID: 24094768). Cyramza (ramucirumab) is FDA approved for use as a monotherapy or in combination with paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma who progressed on chemotherapy, in combination with erlotinib as first-line therapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations or L858R, in combination with decetaxel in patients with NSCLC who progressed on prior therapy, in combination with FOLFIRI in patients with colorectal cancer who progressed on prior therapy, and as monotherapy in patients with hepatocellular carcinoma who have received sorafenib (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown gastric adenocarcinoma not applicable Ramucirumab FDA approved Actionable In a Phase III trial (REGARD) that supported FDA approval, treatment with Cyramza (ramucirumab) improved median overall survival (5.2 vs 3.8 mo, HR=0.776, p=0.047) in aptients with compared to placebo in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma whose disease progressed after chemotherapy (PMID: 24094768; NCT00917384). 24094768 detail...
Unknown unknown gastroesophageal junction adenocarcinoma not applicable Ramucirumab FDA approved Actionable In a Phase III trial (REGARD) that supported FDA approval, treatment with Cyramza (ramucirumab) improved median overall survival (5.2 vs 3.8 mo, HR=0.776, p=0.047) in aptients with compared to placebo in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma whose disease progressed after chemotherapy (PMID: 24094768; NCT00917384). 24094768 detail...