Incyte Reaches Agreement With FDA On SPA For JAK1/JAK2 Inhibitor

Incyte has reached an agreement with the FDA regarding a Special Protocol Assessment. This SPA is on the design of a pivotal phase III trial for JAK1/JAK2 Inhibitor – INCB18424 in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF).

COMFORT-I is a double-blind, placebo-controlled phase III trial, comparing the efficacy and safety of INCB18424 to placebo in 240 patients with PMF, PPV-MF or PET-MF. The trial is expected to begin in August. COMFORT-II, a second phase III trial being conducted in Europe, has started patient enrollment in July.

Paul Friedman, president and CEO of Incyte, said: “Finalization of the SPA is an important achievement and we look forward to initiating COMFORT-I as quickly as possible in over 90 clinical sites in the US, Canada and Australia. The primary endpoint of COMFORT-I is the proportion of patients achieving a 35% or greater reduction in spleen volume as compared to patients receiving placebo.

Key secondary endpoints include measuring the duration of the 35% or greater reduction in spleen volume among the patients initially randomized to INCB18424, and the proportion of patients who achieve a 50% or greater reduction in symptoms as measured by a modified version of the Myelofibrosis Symptom Assessment Form,” he added.