Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial

RCT in 204 patients found that overall survival was longer with the oral multi-kinase inhibitor regorafenib than it was with placebo (8.8 vs.6.3 months; HR 0.55, 95% CI 0.40–0.77, p=0.00016). ADRs occurred in 97% of regorafenib recipients and 46% on placebo.

The researchers note that this phase 3 trial is the second to show an overall survival benefit with regorafenib compared with placebo in patients with treatment-refractory metastatic colorectal cancer.

 

A commentary compares and contrasts this trial with the CORRECT trial, a placebo-controlled phase 3 study that led to approval of regorafenib in patients with refractory metastatic colorectal cancer. It notes that a predictive biomarker to allow selection of patients most likely to benefit from regorafenib has so far been elusive, and despite widespread research, no predictive biomarker of efficacy for any anti-angiogenic drug has been identified so far. Clinical trials testing regorafenib in early lines, such as maintenance monotherapy, first-line combinations with chemotherapy with or without VEGF-targeted drugs, or in patients that are anti-angiogenic-naive, are underway.