Incyte Corporation announced that the phase 2 sub-study of ruxolitinib or placebo in combination with regorafenib in patients with relapsed or refractory metastatic colorectal cancer (CRC) and high C-reactive protein (CRP) will be stopped early. The decision to stop the sub-study was made after a planned interim analysis of the high CRP subgroup demonstrated that ruxolitinib plus regorafenib did not show a sufficient level of efficacy to warrant continuation. This phase 2 randomized, double-blind study (INCB 18424-267) of patients with relapsed or refractory metastatic CRC included an open-label, safety run-in, to confirm the safety of the ruxolitinib plus regorafenib combination in subjects with relapsed or refractory metastatic CRC as well as a randomized phase of the study.

The randomized phase of the study included 2 sub-studies targeting separate populations of patients with CRC based on levels of systemic inflammation, as measured by the modified Glasgow Prognostic Score (sub-study 1 CRP >10 mg/L and sub-study 2 CRP = 10 mg/L). Patients in each sub-study were randomized 1:1 to receive ruxolitinib plus regorafenib or regorafenib plus placebo.