LBA-001Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: Pooled efficacy and safety across two global randomized Phase 3 studies (REACH-2 and REACH)

Background: Ramucirumab (RAM), a human IgG1 monoclonal antibody, inhibits ligand activation of VEGFR2. REACH and REACH-2 were two global, randomized, double-blind, placebo (PBO)-controlled multicenter, phase 3 studies of RAM vs PBO in patients with HCC after prior sorafenib. REACH-2 was designed to confirm the ramucirumab treatment benefit for patients with baseline AFP ≥400 ng/mL first observed in the prespecified subgroup of patients in REACH with AFP ≥400 ng/mL. The primary endpoint of REACH-2 was met demonstrating an improved overall survival (OS) compared to PBO, a result consistent with that in patients with AFP ≥400 ng/mL in REACH. Pooled analyses of patients from REACH-2 and REACH with baseline AFP ≥400 ng/mL was performed.