Pacritinib: Preliminary Phase III data

Preliminary data from 221 patients with myelofibrosis and platelet counts <100,000/uL in the intent-to-treat (ITT) population of the open-label, international Phase III PERSIST-2 trial showed that oral pacritinib given as 200 mg twice daily or 400 mg once daily met the co-primary endpoint of improving the proportion of patients with a >=35% reduction in spleen volume from baseline to week 24 compared to investigator’s choice of best available therapy, including Jakafi ruxolitinib (p<0.01). Pacritinib missed the co-primary endpoint of improving the proportion of patients with a total symptom score reduction of >=50% per the modified MPN-SAF 2.0 diary from baseline to week 24 compared to investigator’s choice of best available therapy (p=0.0791). The co-primary endpoints compared pooled data for both dosing regimens of pacritinib to the control group. CTI said the incidence of cardiac and bleeding adverse events, including deaths, was similar across treatment arms and that overall mortality rates were comparable between arms. ...