Embattled Pacritinib Trial Achieves One of Two Primary Endpoints

CTI BioPharma published top-line results from a Phase III clinical trial comparing pacritinib with best available therapy, including ruxolitinib, for the treatment of patients with myelofibrosis with platelet counts less than 100,000 per microliter. Pacritinib is an oral multikinase inhibitor.

Preliminary results showed the trial, PERSIST-2, met one of its co-primary endpoints by reducing spleen volume. The trial did not meet its other co-primary endpoint of achieving greater than 50 percent reduction in Total Symptom Score.

The FDA had placed a full clinical hold on the company’s trials of pacritinib in myelofibrosis in February, and recommended dose exploration studies, after results from PERSIST-2 showed a decrease in survival consistent with results from the previous PERSIST-1 trial. At the time, CTI BioPharma withdrew its NDA to review PERSIST-2 safety and efficacy data.