Subgroup analysis of East Asian patients in REGARD: A phase III trial of ramucirumab and best supportive care for advanced gastric cancer.

Abstract

We describe a subgroup analysis assessing the efficacy and safety of ramucirumab monotherapy in East Asian (EA) patients from the REGARD trial. Patients with advanced gastric or gastroesophageal junction adenocarcinoma with progressive disease were randomized 2:1 to receive ramucirumab (8mg/kg) plus best supportive care (BSC) or placebo plus BSC every 2weeks. Post hoc subset analyses were performed on the EA and non-EA intention-to-treat populations. Of 355 intention-to-treat patients, 26 patients from EA were randomized to ramucirumab (n=18) or placebo (n=8). Median overall survival was 6.5 months in the ramucirumab arm and 4.8 months in the placebo arm (hazard ratio [HR] 0.69; 95% confidence interval [CI], 0.27-1.82) for EA patients, and 5.2 months in the ramucirumab arm and 3.8 months in the placebo arm (HR 0.78; 95% CI, 0.60-1.02) for non-EA patients. The rate of disease control was numerically higher in ramucirumab patients versus placebo; 61% versus 38% respectively for EA patients, and 48% versus 22% for non-EA patients. The incidence of grade ≥3 treatment emergent adverse events was higher in the ramucirumab arm compared to placebo (39% vs 13%). Despite limitations, this subgroup analysis suggests that ramucirumab monotherapy improves efficacy outcomes with a tolerable safety profile in EA patients with previously treated advanced gastric cancer.