A randomized, double-blind, placebo-controlled Phase III study of ramucirumab versus placebo as second-line treatment in patients with hepatocellul...

Date 29 June 2016
Event ESMO World Congress on Gastrointestinal Cancer 2016
Session ESMO World Congress on Gastrointestinal Cancer 2016 - Abstracts book
Presenter Zhu Andrew
Citation Annals of Oncology (2016) 27 (2): 1-85. 10.1093/annonc/mdw199
Authors Z. Andrew1, G. Peter2, K. Masatoshi3, F. Richard4, Y. Ling5, A. Paolo6, L. Josep7
  • 1Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA, /
  • 2University Medical Center Mainz, Mainz, Germany, /
  • 3Kinki University School of Medicine, Osaka-Sayama City, Japan, /
  • 4University of California Los Angeles, Los Angeles, California, USA, /
  • 5Eli Lilly and Company, Bridgewater, New Jersey, USA, /
  • 6Eli Lilly and Company, Indianapolis, Indiana, USA, /
  • 7Mount Sinai School of Medicine, New York, New York, USA, /

Abstract

Ramucirumab (Ram) is a humanized IgG1 monoclonal antibody that inhibits VEGF-A, C and D activation of the vascular endothelial growth factor receptor 2 (VEGFR2). The Phase 3 REACH study assessed Ram versus placebo (PBO) in the treatment of patients with advanced hepatocellular carcinoma (HCC) after prior sorafenib. A significant improvement in overall survival (OS) in the overall population (N = 565) was not demonstrated (Hazard Ratio (HR) = 0.866; p = 0.1391). Ram was well tolerated. A meaningful improvement in OS was observed in a pre-specified subgroup of patients with baseline alpha-fetoprotein (AFP) ≥400 ng/mL (n = 250, HR = 0.674; p = 0.0059), with significant improvements in PFS (HR = 0.699, p = 0.0106) and ORR (6.7% Ram vs 0.8% PBO, p = 0.0254). In patients with elevated AFP, a strong trend for delay in deterioration of patient reported symptoms (p = 0.054) and delay in performance status (PS) deterioration (p = 0.057) was also observed in pts treated with Ram compared to placebo.