Rilomet-1: an International Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Trial of Rilotumumab Plus Epirubicin, Cisplatin and Capecitabine (Ecx) As First Line Therapy in Patients with Advanced Met-Positive Gastric or Gastroesophageal Junction (G/Gej) Adenocarcinoma

Background: Rilotumumab is an investigational, fully human monoclonal antibody to hepatocyte growth factor/scatter factor that inhibits signaling through the MET receptor. In a randomized phase 2 study in patients with advanced G/GEJ adenocarcinoma, addition of rilotumumab every 3 weeks (Q3W) to ECX showed trends toward improved overall survival (OS; 10.6 vs 8.9 months; hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.45–1.09) and progression-free survival (PFS; 5.7 vs 4.2 months; HR, 0.60; 95% CI, 0.39–0.91) vs ECX alone. In patients with high tumor MET expression, the treatment effect of rilotumumab combined with ECX was significantly enhanced (median OS, 10.6 vs 5.7 months; HR, 0.46; 95% CI, 0.24–0.87).