Multinational phase 3 trial of regorafenib for refractory advanced gastric or esophagogastric junction cancer

Treatment options for refractory advanced gastric and esophagogastric junction cancer (AGOC) are limited. The multinational phase 3 INTEGRATE IIa trial evaluated the overall survival effect of the oral multikinase inhibitor regorafenib plus best supportive care versus placebo plus best supportive care among patients with refractory AGOC who failed ≥ 2 prior therapies. The study found that Regorafenib improved overall survival versus placebo: median OS was 4.5 months versus 4.0 months (HR 0.68; p=0.006) with 12-month survival rates of 19% versus 6%. There were no differences in the OS impact of regorafenib between prespecified subgroups. Regorafenib improved progression-free survival (HR 0.53; p<0.0001) and delayed deterioration of global quality of life (HR 0.68; p=0.0043). Toxicity profile was consistent with that in previous reports. The authors conclude that regorafenib improved survival compared with placebo in refractory AGOC.