Preliminary results demonstrated that the Persist-2 trial met one of the co-primary endpoints showing a statistically significant response rate in spleen volume reduction in patients with myelofibrosis treated with pacritinib compared to BAT, including the approved JAK2 inhibitor ruxolitinib. Although the Persist-2 trial did not meet the other co-primary endpoint of greater than 50 percent reduction in Total Symptom Score, the preliminary analysis approached marginal significance compared to BAT. The co-primary endpoints of the trial were the proportion of patients achieving a 35 percent or greater reduction in spleen volume from baseline to Week 24, as measured by magnetic resonance imaging or computerized tomography and the proportion of patients achieving a total symptom score reduction of 50 percent or greater using MPN-SAF TSS 2.0 diary from baseline to Week 24. The most common treatment emergent adverse events for pacritinib were generally manageable diarrhea, nausea and vomiting. The incidence of cardiac and bleeding adverse events were similar across the arms. Overall mortality rates were comparable between arms.
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