Topline data from RELIEF trial of Jakafi/Jakavi in Polycythemia Vera fails to meet endpoint - Incyte Corp

Incyte Corporation has announced top-line results from RELIEF, a randomized, double-blind clinical trial designed to compare symptom improvement in 110 patients with Polycythemia Vera (PV) treated with Jakafi/Jakavi (ruxolitinib) versus patients treated with hydroxyurea (HU). While positive trends were observed in favor of ruxolitinib, the Phase III multicenter, double-blind, double-dummy, randomized (1:1) study did not achieve statistical significance for the primary endpoint as measured by the proportion of patients with ≥ 50% reduction in a defined cluster of symptoms that included tiredness, itching, muscle aches, night sweats and sweats while awake at week 16 compared to baseline.

Topline results showed a 43.4% symptom response rate in the ruxolitinib arm and a 29.6% symptom response rate in the hydroxyurea arm. Full data from the RELIEF trial are expected to be presented at an upcoming scientific meeting. Further analyses of RELIEF are underway to evaluate what factors may have contributed to a symptom control rate for patients on stable doses of HU that was five to six times higher than that seen in the best available therapy control arm of the RESPONSE trial, and which led to an underpowering of the RELIEF trial.