Phase III, randomized, double-blind, multicenter, placebo (P)-controlled trial of rilotumumab (R) plus epirubicin, cisplatin and capecitabine (ECX) as first-line therapy in patients (pts) with advanced MET-positive (pos) gastric or gastroesophageal junction (G/GEJ) cancer: RILOMET-1 study.

4000 Background: R is a fully human monoclonal antibody to hepatocyte growth factor. A phase 2 study showed improved overall survival (OS) and progression-free survival (PFS) with R + ECX vs P + ECX in MET-pos G/GEJ cancer (Lancet Oncol 2014;15:1007). This phase 3 trial evaluated the efficacy and safety of R + ECX in MET-pos G/GEJ cancer. Methods: Key eligibility criteria: ≥ 18 yr; previously untreated, pathologically confirmed unresectable advanced G/GEJ adenocarcinoma; ECOG score 0–1; tumor MET-pos by IHC; HER2-negative. Pts were randomized 1:1 to receive ECX (IV epirubicin 50 mg/m2 D1, IV cisplatin 60 mg/m2 D1, oral capecitabine 625 mg/m2BID D1−21) + R 15 mg/kg or P IV Q3W and stratified by disease extent (locally advanced vs metastatic) and ECOG score (0 vs 1). Primary endpoint: OS. A log-rank test stratified by randomization factors compared OS between arms. The study was powered to detect a HR of 0.69. Key secondary endpoints: PFS, 12-mo survival rate, objective response rate (ORR), safety and pharm...