Ramucirumab treatment in patients with gastric cancer/gastroesophageal junction adenocarcinoma: Secondary analysis of efficacy and safety results of 4 dosing regimens in the phase II trial I4T-MC-JVDB.

117Background: Ramucirumab (RAM) is approved for treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma with disease progression after prior platinum and/or fluoropyrimidine chemotherapy at 8 mg/kg every 2 weeks (Q2W). Previous phase 3 trials indicated that efficacy of RAM correlated with exposure. While the primary objectives of the open-label RAM monotherapy JVDB study were pharmacokinetics and safety, a secondary analysis was conducted on efficacy and safety of the 3 higher exposure regimens vs. the standard regimen. Methods: Patients (n = 164) were randomized 1:1:1:1 to 4 treatment arms: 8 mg/kg Q2W (Arm 1), 12 mg/kg Q2W (Arm 2), 6 mg/kg every week (Arm 3), and 8 mg/kg Days 1 and 8 (D1D8) every 3 weeks (Q3W) (Arm 4). Treatment-emergent adverse events (TEAEs) were graded by NCI CTCAE v4.0. Tumor response was assessed by RECIST 1.1. Results: Median (months) progression-free survival (PFS) of the 3 arms and overall survival (OS) of 2 arms was increased compared to the standard r...